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BALANCE SYSTEM SDOPERATION/SERVICE MANUAL950-440950-441950-444

BIODEXBiodex Medical Systems, Inc.

20 Ramsey Road, Shirley, New York, 11967-4704, Tel: 800-224-6339 (Int’l 631-924-9000), Fax: 631-924-9338, Email: [email protected], www.biodex.com

FN: 10-205 Rev C 2/14

This manual covers installation and operation procedures

for the following products:

#950-440 System, Balance SD, 115 VAC#950-441 System, Balance SD, 230 VAC#950-444 System, Balance SD, 100 VAC

BALANCE SYSTEM

CAUTION: Federal law restricts this device to sale or on the order of a medical practitioner. When

prescribed for therapeutic purpose, a physician should clearly define the parameters of use (i.e.,

total work, maximum heart rate, etc.) to reduce the risk of patient injury.

ATTENTION: Droit fédéral limite ce dispositif à la vente ou de l'ordre de la profession médicale.

Lorsque prescrits à des fins thérapeutiques, un médecin devrait clairement définir les paramètres

d'utilisation (p. ex., total travail, fréquence cardiaque maximale, etc.) afin de réduire le risque

de blessure de patient.

— II —

Before Proceeding ..............................................................................................................................IVDefinition of Symbols ........................................................................................................................V

1. Introduction ......................................................................................................................................1-12. System Specifications ......................................................................................................................2-13. Assembly and Installation ..............................................................................................................3-1

• Printer Installation• Parts and Adjustments

4. Clinical Considerations....................................................................................................................4-1• General Clinical Considerations• Additional Considerations for Fall Risk Screening and Conditioning Program

5. Applications ......................................................................................................................................5-1• Orthopedic and Sports Medicine• Fall Prevention• Reference Notes

6. Getting Started ..................................................................................................................................6-1• Accessing the Main Menu• Display Panel Keys Described• Screen Keys

7. The Training Routine ......................................................................................................................7-1• Postural Stability Training • Limits of Stability (LOS) Training • Weight Shift Training • Maze Control Training • Random Control Training • Percent Weight-Bearing Training • Create, Save and Recall Custom Protocols

8. Testing ..............................................................................................................................................8-1• The Postural Stability Test• The Limits of Stability Test• Athlete Single Leg Stability Testing• Performing a Fall Risk Test• Clinical Test of Sensory Integration and Balance CTSIB overview

9. Reports................................................................................................................................................9-1• Report Parameters Defined• Progress Reports • Sample Balance Reports

10. Data ..................................................................................................................................................10-1• Assessing Limits of Stability With The Biodex Balance System• Understanding Patient Performance• Balance System Statistics Defined• Changing Normative Data Default

11. System Utilities................................................................................................................................11-1• Configuration ..............................................................................................................................11-2• Patient Management ..................................................................................................................11-7

12. Reimbursement ..............................................................................................................................12-113. General Maintenance ....................................................................................................................13-1Appendix A: Calculation of Limits of Stability Direction Control ................................................A-1Appendix B: Normative Data Referenced in Predictive Values Report ........................................B-1Appendix C: CTSIB Normative Data Collection and Reliability ....................................................C-1Appendix D: Balance Overview ..........................................................................................................D-1Appendix E: Electromagnetic Compatibility ......................................................................................E-1Appendix F: Cleaning and Maintenance ............................................................................................F-1Appendix G: References. Bibliography available at www.biodex.com/balance ........................G-1Replacement: ............................................................................................................................................R-1

TABLE OF CONTENTS

— III — TABLE OF CONTENTS

DEFINITION OF SYMBOLS — IV —

DEFINITION OF SYMBOLS

Biodex Medical Systems, Inc. © 2012

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Carefully read these instructions prior to use

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General Warning

General Mandatory Action

Dangerous Voltage

“On” Power

“Off” Power

Earth (ground)

Alternating Current

Fuse

USB Connector/Cable

Waste in Electrical Equipment

Date of Manufacture

Type B Applied Part

CE Mark

Certified for Safety by ETL Intertek

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— V — BEFORE PROCEEDING

• This system should be operated only by qualified personnel.

• Ensure that all system wiring and cables are routed away from any area where they mightbe stepped on or rolled over by wheeled equipment.

CAUTION: To avoid risk of electric shock, this equipment must only be connected to a supplymains with protective earth.

ATTENTION: Pour éviter le risque de choc électrique, cet équipement doit uniquement être con-necté à un approvisionnement conduites avec la terre protectrice.

• The plug is considered the method of disconnecting the product from mains power. Do notplace the product in a position where the plug is not easily accessible.

• Connecting electrical equipment to power outlet on the back of the unit effectively leads to creat-ing a medical electrical system, and can result in a reduced level of safety. This outlet is intendedonly for use with an approved printer equipped with an IEC cord (see System Specifications list).

• Be aware that use of Biodex technology requires professional expertise for discerning appro-priate treatment techniques. Each subject’s unique situation should be taken into accountbefore beginning any type of testing or rehabilitation program. Be sure you fully comprehendthe operating instructions, as well as the considerations, both physical and clinical, discussedthroughout the manual before attempting to set up a subject for testing or exercise. Practicesetups and positioning with a healthy subject before attempting to set up an injured patient.

• To assist our users and stimulate interest in developing protocols, this manual contains a”Clinical Considerations” section where appropriate. These comments come from the clini-cal experience of our users as well as from published journals.

• The product is intended to remain in one location during operation. The product is provid-ed with wheels for relocation, and should be used when performing this operation. It is rec-ommended that two persons move the product.

CAUTION: It is recommended that patients wear non-skid foot wear when using this device.

ATTENTION: Il est recommandé que les patients portent des pieds antidérapants usure lors del'utilisation de ce dispositif.

NOTE: Service should be provided by qualified personnel only. Please do not attempt installation orrepair on your own. Call Biodex Customer Service first, they’ll be glad to help.

CAUTION: Modifications to this product are not allowed. Unauthorized modification of the prod-uct can result in hazards to the operator and patient and will void the manufacturer’s warranty.Do not modify this equipment without authorization from the manufacturer.

ATTENTION: Des Modifications à ce produit ne sont pas autorisées. Modification non autoriséedu produit peut entraîner des risques pour l'opérateur et le patient et annulera la garantie du fabri-cant. Ne modifiez pas cet équipement sans l'autorisation du fabricant.

CAUTION: If this equipment is modified, appropriate inspection and testing must be conducted toensure continued safe use of equipment.

ATTENTION: Si cet équipement est inspection modifiée, appropriée et essais doivent être effectuéspour s'assurer a continué l'utilisation sécuritaire de l'équipement

For disposal information at the product’s end of life, contact Biodex.

For additional technical advice, service or education information, please contact:Biodex Medical Systems, Inc., 20 Ramsey Road, Shirley, New York 11967-4704 1-800-224-6339 (Int’l 631-924-9000) or [email protected]

BEFORE PROCEEDING

The Balance System SD has received the following certifications, and falls within the followingclassifications:

• ETL Listed Electrical Equipment, Laboratory Use; Part 1, General Requirements for Safety conforms to UL 60601-1, CAN/CSA C22.2 No: 601-1-M90, IEC 60601-1, IEC 60601-1-4 and IEC 60601-1-2 and CE Marked.

• FDA Class II Equipment

• EC Certificate: EC # 4132458

• NOTE: Circuit diagrams for this product are provided in the Schematics section at theback of this manual.

• Authorized European Community Representative:

Emergo Europe

Molenstraat 15

2513 BH, The Hague

The Netherlands

• Type B Applied Part

•

• Electromagnetic Compatibility: This equipment complies with the Medical Equipment ICC 60601-2 EMC Standard.

PRODUCT CERTIFICATIONS AND CLASSIFICATIONS

PRODUCT CERTIFICATIONS — VI —

EC REP

CAUTION: Federal Law restricts this device to sale by, or on the order of a medical practitioner.When prescribed for therapeutic purpose, a physician should clearly define the parameters of use(i.e., total work, maximum heart rate, etc.) to reduce the risk of patient injury.

ATTENTION: La Loi Fédérale restreint cet artifice à la vente par, ou sur l'ordre d'un praticienmédical. Quand prescrit pour le but thérapeutique, un docteur devrait clairement définir lesparamètres d'utilisation (c'est-à-dire, travail total, taux maximum du cœur, etc.) pour réduire lerisque de blessure patiente.

Follow the assembly and installation instructions document.

Before using this device, read the entire operation manual carefully. Failure to read themanual may result in user error or inaccurate data. Be sure to save all provided docu-ments for future reference.

Make certain to understand all warning and caution labels as explained in the BeforeProceeding section of this manual.

The Balance System SD should be used only as specified in the operation manual.

The Balance System SD is designed for use in a patient environment.

See Chapter 2 for Balance System SD specifications.

This medical electrical equipment requires special precautions regarding EMC and mustbe installed and placed into service according to EMC information provided in this manu-al. Electromagnetic compliance definition is provided in Appendix E.

Reference Cleaning and Maintenance Chapter 13.

Operation for: 115-230 VAC, 50/60 Hz.

Only use approved power supplies.

CAUTION: To avoid risk of electric shock, this equipment must only be connected to supply mainswith protective earth.

ATTENTION: Pour éviter le risque de choc électrique, cet équipement doit uniquement être con-necté à un approvisionnement conduites avec la terre protectrice.

IMPORTANT SAFETY INFORMATION

— VII — IMPORTANT SAFETY INFORMATION

CAUTION: The plug is considered the method of disconnecting the product from mains power.Do not place the product in a position where the plug is not easily accessible.

ATTENTION: Le bouchon est considérée comme la méthode de déconnexion du produit d'alimen-tation. Ne placez pas le produit dans une position où le bouchon n'est pas facilement accessible.

CAUTION: The product is intended to remain in one location during operation. The product isprovided with wheels for relocation, and should be used when performing this operation. One per-son can move the product.

ATTENTION: Le produit est voulu rester dans un emplacement pendant l'opération. Le produitest fourni avec les roues pour la relocalisation, et devrait être utilisé en exécutant cette opération.Une personne peut déplacer le produit.

BALANCE SYSTEM SD WARRANTY

IMPORTANT SAFETY INFORMATION — VIII —

1. Instrumentation

A. This equipment and its accessories are warranted by BIODEX MEDICAL SYSTEMS, INC.,against defects in materials and workmanship for a period of two years from the date of ship-ment from BIODEX MEDICAL SYSTEMS, INC. During the warranty period, BIODEX MED-ICAL SYSTEMS, INC. will in its sole discretion, repair, recalibrate or replace the equipmentfound to have such defect, at no charge to the customer.EXCEPT AS STATED ABOVE, THERE ARE NO WARRANTIES, EXPRESSED OR IMPLIED,INCLUDING WITHOUT LIMITATION WARRANTIES OR MERCHANTABILITY OR FITNESSFOR USE. BIODEX DOES NOT ASSUME LIABILITY FOR INCIDENTAL, CONSEQUENTIALOR INDIRECT DAMAGES INCLUDING LOSS OF USE, SALES, PROFITS OR BUSINESSINTERRUPTION.B. This warranty does not apply if the product, as determined by BIODEX MEDICAL SYS-TEMS, INC., is defective due to abuse, misuse, modification or service performed by other thana BIODEX MEDICAL SYSTEMS, INC. authorized repair and calibration facility. Misuse andabuse include, but are not limited to, subjecting limits and allowing the equipment to becomecontaminated by radioactive materials.C. In order to obtain warranty repair service, the equipment or system component must bereturned freight pre-paid to one of our facilities. The Return Materials Authorization number(R.M.A. #) should be included, along with a statement of the problem. Equipment or systemcomponent will be returned transportation prepaid.

2. Calibration

A. Instruments are warranted to be within their specified accuracy at the time of shipment. If aquestion arises and BIODEX MEDICAL SYSTEMS, INC. determines that the initial calibration isin error, the instrument will be recalibrated at no charge.B. Mechanical products are warranted to meet written specifications and tolerances at the timeof shipment.C. The return policy is as stated in paragraph 1.C.

3. Warranty is non transferable.

4. Non-Warranty Service

A. Repairs and/or replacements not covered by this warranty may be performed by BIODEXMEDICAL SYSTEMS, INC. at a factory authorized service location. Estimates of repair chargesmay be requested, however, a charge for estimate preparation may apply if the repair is laternot authorized by the customer.B. The cost of transportation into and out of the service location will be the responsibility of thecustomer.

BALANCE SYSTEM SD WARRANTY

— IX — BALANCE SYSTEM SD WARRANTY

Service ProcedureIf you think you have a service problem, take the following action.

1. Check to see that the problem occurs more than once.

2. Refer to the instruction manual and operations procedure.

3. Refer to the instruction manual Troubleshooting Guide.

If you still think you have a service problem, call BIODEX MEDICAL SYSTEMS, INC., Service Department at (800) 224-6339.

Keep yourself and the phone next to the equipment.1. Service will ask you for a brief description of the problem. We will ask specific questions

about the malfunction that occurred. This diagnostic process may take a few minutes, so call us when you have time to spare.

2. After taking the information, we will advise on the action we will take.

3. Sometimes service personnel must consult with engineering and it may take time to get backto you. Be sure to let the service representative know your schedule so that we can call at aconvenient time.

4. The return call may be from a person other than whom you first reported the problem to.

5. After analyzing the problem, we will decide if the unit must be returned to us for repair, or replacement parts will be sent.

6. If the unit must be returned, it will be given a Return Materials Authorization Number (R.M.A. #) number by us. Pack the system in the carton that it was originally shipped in, or pack it safely and securely to avoid shipping damage. It is the customer's responsibility for any damage that occurs during shipping.

7. Non-warranty/non-service contract charges for repair are as follows:

a. Materials+

b. Time+

c. Shipping Charges

Contact InformationBiodex Medical Systems, Inc.20 Ramsey Road, Shirley, New York, 11967-4704 Tel: 800-224-6339 (Int’l 631-924-9000)Fax: 631-924-8355 Email: [email protected], www.biodex.com

CONTENTS

BALANCE SYSTEM SD WARRANTY — X —

Figure 1.1: The Biodex Balance System SD primary components and adjustment mechanisms.

1. INTRODUCTION

— 1-1 — INTRODUCTION

Auxiliary Serial andUSB Printer Ports

Adjustable height display toaccommodate each patient

Adjustable support handles

Color printer withstand - included

Transportwheels allow easy relocation

Features both staticand dynamic balance capabilities

Locking surface ensuressafe “on-off” patientmovement

12.1" High resolution color touch-screen LCD display

Ethernet connection accommodateswired and wireless printing.

Featuring five test protocols, six training modes and intuitive "touch-screen" operation, theBalance System SD allows testing and training in both static and dynamic formats. Extremely ver-satile, it is the only system that provides fast, accurate Fall Risk Screening and Conditioning forolder adults, used as a balance assessment tool for concussion management, plus closed-chain,weight-bearing assessment and training for lower extremity patients.

Using this unique device, clinicians can assess neuromuscular control by quantifying the ability tomaintain dynamic bilateral and unilateral postural stability on a static or unstable surface.

Use any of five test protocols including Fall Risk Screening, Athletic Single-Leg Injury Screening,Dynamic or Static Limits of Stability, Postural Stability and Clinical Test of Sensory Integration ofBalance (CTSIB). The Balance System SD also serves as a valuable training device to enhancekinesthetic abilities that may provide some degree of compensation for impaired proprioceptivereflex mechanisms following injury.

An easy-to-follow touch-screen format makes the system simple to learn and operate, leading theuser step-by-step through testing protocols and training modes. All test results and training ses-sions are documented on easy to read 8.5" x 11" reports which can be placed into the patient’s file.Comparisons to normative data can be made for population-specific tests using the Fall Screening,Athletic Single Leg, Limits of Stability and CTSIB protocols.

1. INTRODUCTION

INTRODUCTION — 1-2 —

Dimensions:Base: 30" w x 44" depth x 8" h (76 x 112 x 20 cm)Platform: 21.5" dia (55 cm)Display Height: Adjustable from 53" to 68" h above platform (135 x 173 cm); 76" h (193 cm) maximum from floor.

Support Rails: Adjustable from 25" to 36.5" above platform (64 to 93 cm). Rails can swing away from platform when not in use.

Platform Tilt: 20 degrees from horizontal in all directions

Stability Levels: Twelve levels, plus locked for static measurements

Game Port: Simulates joystick output suitable for PC compatible game port

Display Specifications:Display Size and Type: 12.1" (30.7 cm); color touch screen.Display resolution: 800 x 600 Operating System: Windows CE 6.0 R3Printing: PCL printing via USB port (see list of compatible printers)Memory: 256 MBAudio:

Audio out with standard stereo line jackVideo Out Display: supports simultaneous analog up to 800 x 600 resolution

User Interface and Device Capabilities: USB ports: Four 1.1 host ports to support

Mass Storage Device: USB Thumb driveKeyboardMouse wired and wireless to allow for remote control operation. Plus:(1) Remote CRT connector(1) Serial communication port

Operating Temperature Range: 59° F to 86° F (15° C to 30° C)

Operating Humidity Range: 30% to 75%

Transport/Storage Temperature Range: -4° F to 140° F (-20° C to 60° C)

Transport/Storage Humidity Range: 20% to 80% non-condensing

Printer: HP DeskJet

Printer Stand: 24" x 24" (61 x 61 cm)

Patient Capacity: Up to 400 lb (136 kg)

Weight: 196 lb (89 kg)

Power: 115 VAC, 50/60 Hz, 15 amp line or 230 VAC, 50/60 Hz, 15 amp line

Power Rating: 350 watts

Certification: ETL listed to UL 60601-1 and CAN/CSA C22.2 No.:601-1-M90. CE conformity to EN 60601-1, EMC compliance to EN 606 01-1-2.

Warranty: Two-years parts; one-year labor

2. SYSTEM SPECIFICATIONS

— 2-1 — SYSTEM SPECIFICATIONS

Compatible Printers *PCL printers specifically HP H470HP 6000HP 6940HP 6940dtHP 6988HP 9800HP K5400HP D5360HP 5650HP 5550

CoMPatIBle PoINtING DeVICeS*Manufacturer Model # Device type Logitech M500 MouseSeal Shield SSMSV5 MouseTargus AMU59US MouseRazer Naga RZ01-0028 MouseMicrosoft 1049 MouseBelkin F5L017-USB-BLK MouseToshiba PA3571U-1ETB MouseMicrosoft 1422 MouseTargus AMU75US MouseMicrosoft 1056, 1051 MouseLogitech V220 MouseHP WX414AA Mouse Dynex DX-PWLMSE MouseToshiba PA3651U-1ETC MouseLogitech G500 910-001259 MouseBTC M859C MouseLogitech M-BJ79 MouseDell MOA8BO MouseDell M-UK DEL3 MouseManhattan 176569 Mouse

CoMPatIBle KeYBoaRDS*Manufacturer Model # Device type Mini Keyboard ACK-5010U USB KeyboardAdesso AKB-210 KeyboardAdesso WKB-4000US KeyboardAdesso ACK-540UB KeyboardAdesso AKB-110B Keyboard

* Printers and other devices are subject to market availability. Please check with Biodex customer service if questions arise.

Authorized European Community Representative:

Emergo EuropeMolenstraat 152513 BH, The HagueThe Netherlands

CONTENTS

SYSTEM SPECIFICATIONS — 2-2 —

EC REP

The Biodex Balance System SD is shipped in a single carton. Except for the printer, which the usermust install as explained below, the entire system is factory assembled and ready to operate.

If desired, the system can be configured for PC computer compatibility, allowing the foot plateto be used like a joystick for interactive video game use. Joystick options are discussed in theSystem Utilities chapter.

PRINteR INStallatIoN(See Figures 3.1 and 3.2)

CAUTION: It may be necessary to have the help of another person to steady the printer during thefollowing procedure.

ATTENTION: il peut être nécessaire d'avoir l'aide d'une autre personne pour stabiliser l'impri-mante au cours de la procédure suivante.

1. Refer to the supplied printer manual to unpack the printer and ensure that it has not beendamaged by shipping.

2. Position the printer on the printer stand as shown.

3. Locate the black printer power cable. Plug the small end into the power receptacle on theback of the printer. Do not connect any other equipment to this receptacle.

4. Plug the AC plug end of the power cable into power cable port on the back, lower base ofthe Balance System.

5. Locate the white USB cable. Connect one end of the cable to the USB port on back of theBalance System display. Connect the other end of the cable to the USB port at the back ofthe printer directly above the power cable port.

6. Ensure both cables are positioned so that they will not interfere with the patient or getcaught in the Balance System platform or handles.

7. Insert several sheets of paper into the printer paper holder. Insert the paper holder into thetop of the printer so that the open end interlocks with the printer and the paper faces outtoward you.

8. With power ON to the Balance System, press the <Power ON> switch on the printer. Ensurethe printer's green Ready LED comes on to indicate the printer is receiving power. Refer tothe supplied printer manual for additional printer information.

3. ASSEMBLY & INSTALLATION

— 3-1 — ASSEMBLY & INSTALLATION

Figure 3.1. The printer power cable should be plugged into the AC receptacle on the rear base of the display support post. The printer USB cable should be plugged into the USB port on back of the display.

1. Reset Button2. Remote CRT Monitor Connector3. PS 2 Connector4. Ethernet activity lights. Green indicates connectivity. Yellow indicates activity. 5. Auxiliary Com Port (Serial Port)6. Ethernet Connector (RJ 45)7. PCB activity lights. Green indicates compact flash activity. Yellow indicates power on.8. USB Connectors (suggested to use one of these for printers)

Figure 3.2. Connect the power cable and USB cable to the rear of the printer.

CONTENTS

ASSEMBLY & INSTALLATION — 3-2 —

1 2 3 4 5

6

7

8

PaRtS aND aDjuStMeNtS(See Figure 3.3.)

Mechanical adjustments to the Biodex Balance System are straightforward and uncomplicated.In fact, there are only three adjustments that need be addressed to accommodate any patient:Support Handle Position, Display Height and Display Tilt. All other test and exercise functionsare software controlled.

to adjust the Support Handle:

1. To position the Support Handle for patient use, hold the Support Handle while pulling out on the Support Handle Release Pin. Rotate the handle to the desired position. Release the pin to lock the Support Handle in place.

2. To release the Support Handle so that it cannot be used by the patient, hold the handle while pulling out on the Support Handle Release Pin. Fully lower the handle, then release the pin.

ajustement de l’appui

1. Pour régler l’angle de l’appui, le tenir tout en tirant sur le verrou. Trouver la position voulue, relâcher le verrou pour garder la position ainsi trouvée.

2. Pour écarter l’appui, le baisser tout en tirant sur le verrou.

to adjust the Display Height:

1. Loosen the Display Height Locking Knob.

2. Pull up or push down on the display until the desired height is achieved.

3. Tighten the locking knob to secure the display in the desired position.

NOTE: Position the display so that the patient can look straight at it. This will help ensure good postureduring the test or exercise session.

Pour adjuster la hauteur de l’ecran

1. Desserrer la mollette de réglage de hauteur.

2. Déplacer l’écran à la hauteur voulue.

3. Serrer la mollette.

to adjust the Display tilt:

1. Simply tilt the Display as required by patient or testing/exercise protocol.

ajustement de l’inclinaison de l’ecran

1. Pivoter l’écran pour obtenir l’angle voulu.

4. PARTS AND ADJUSTMENTS

— 3-3 — ASSEMBLY & INSTALLATION

Figure 3.3. Balance System adjustment mechanisms.

CONTENTS

ASSEMBLY & INSTALLATION — 3-4 —

Auxiliary Serial andUSB Printer Ports

Adjustable height display toaccommodate each patient

Adjustable support handles

Color printer withstand - included

Transportwheels allow easy relocation

Features both staticand dynamic balance capabilities

Locking surface ensuressafe “on-off” patientmovement

NEW 12.1" High resolution color touch-screen LCD display

Prior to allowing any patient to use this device, make certain to read and comprehend thisentire manual. Ensure that you are completely familiar with all aspects of adjustment, trainingand testing, as well as patient history. Be sure to adhere to the following clinical guidelines at alltimes when using this system.

NOTE: Never allow a patient to use the Balance System while unsupervised.

CoNSIDeRatIoNS ClINIQueSAvant d’appliquer le systäme de stabilité à un patient, lire avec soin la présente notice. Il faut sefamiliariser avec tous les aspects de réglage, d’entraâneemnt et d’examen ainsi qu’avec ledossier du patient. Respecter les consigues indiquées ci-dessous lors de l’utilisation du systéme.

NOTA: Ne jamais laisser un patient sans surveillance sur le systéme de stabilité.

GeNeRal ClINICal CoNSIDeRatIoNS1. All users should have a verbal understanding of the Balance System prior to stepping on the

device.

2. To ensure patient safety, begin each session with the balance platform in the "locked" orstatic position.

NOTE: The Balance System automatically places the platform in the locked position when the unit isturned ON, or after a time period of three minutes when the system is not in use.

3. Adjust support rail and biofeedback display for patient comfort and safety.

4. When dealing with post-operative patients, ensure they possess adequate muscular controlto stabilize the joint prior to placing them on the foot platform. Inadequate muscular controlcould lead to increased joint translation.

5. When patients are working with their eyes closed, ensure that a clinician is ready to assist incase of loss of balance or use the optional patient support stand.

6. Since the entire lower extremity is required to work to stabilize the balance device, ensurethat supporting structures above and below the joint are adequately strengthened prior tobeginning rehabilitation on this device.

7. For optimal operation, ensure the patient is standing in the center of the platform.

8. Patients should progress from "hands-on" to "hands-off" the support handle. This willensure that new or unstable patients have an adequate understanding of the Balance Systemand will help protect the patient against sudden or unexpected movement of the platform.

9. Position the display so that the patient can look straight at it. This will help ensure goodposture during the test or exercise session.

10. There is a learning curve that must be considered when testing with this device. Clinicalresearch suggests three trials be performed prior to testing. For dynamic balance testing, the"default settings" are preselected with three trials per side. This should assist with the learn-ing curve and better average the data.

4. CLINICAL CONSIDERATIONS

— 4-1 — CLINICAL CONSIDERATIONS

CoNSIDeRatIoNS ClINIQueS GeNeRaleS 1. Tout patient doit comrendre les principles du systàme de stabilité avant de s’y mettre.

2. Démarrer toutes les séances avec le platcau en position bloquéc.

NOTA: Lors de la misc sous tension, le systàme de stabilité se met automatiquement en position bloquée. De la màme facan, si le systäme n’est pas utilisé pendant un intervalle de 3 minutes, il sebloque.

3. Régler l’appui et l’ecran pour maximizer le confort et la sécurité du patient.

4. Pour des patients post-opératoires, vérifier avant de les faire monter sur le plateau qu’ils sont capables de stabiliser leurs articulations. Un contrìle insuffisant pourrait les mettre à risque.

5. Si les patients travaillent les yeux fermés, il faut se tenir pràt à les aider ou mettre en place l’appui.

6. Puisque l’utilisation du plateau de stabilité sollicite toutes les articulations de l’extrémité, s’assurer que les cicatrisations sont suffisamment avancées pour supporter l’exercice.

7. Les résultats sont meilleurs avec le patient placé au milieu du plateau.

8. Les patients doivent démarrer avec l’appui et apprendre progressivement à ne plus s’en servir. De cette facon les patients développment leur compréhension du plateau de stabilité en minimisant les risques.

9. La courbe d’apprentissage du systäme peut influencer les résultats d’un examen. La littérature clinique suggàre qu’il faut réaliser trois examens à blanc avant de faire un examen définitif.

10. Régler l’écran droit devant les yeux du patient. Ceci aidera à maintenir une bonne position pendant l’exmen ou l’entraånement.

aDDItIoNal CoNSIDeRatIoNS FoR Fall PReVeNtIoN PRoGRaMSIn addition to the above, the following considerations should also be considered when workingwith patients in a fall prevention program.

1. It is strongly recommended that the Biodex Unweighing System be used in conjunction withbalance training/testing.

NOTE: The Biodex Unweighing System is intended to assist the patient who has balance deficits. Clinicians should not rely on this device to prevent falls.

2. Since the Biodex Balance System allows up to 20-degrees of surface tilt, begin with static or stability level 12 and progress as tolerated.

NOTE: The static setting is most stable, level one is least stable. Levels 12 to 1 provide a full 20 degrees of surface tilt.

3. Patients with extreme weakness or atrophy, especially of the lower extremity, should be closely monitored.

CONTENTS

CLINICAL CONSIDERATIONS — 4-2 —

NOTE: The ankle provides a critical source of sensory input, controlling the degree of sway in elderlypatients.

4. Repeat bouts of balance training where the joint is displaced nearly to its limits have been shown to increase muscle tone, thus increasing muscle spindle sensitivity and enhancing thesomatosensory response.

autReS CoNSIDeRtIoNS PouR DeS PRoGRaMMeS De PReVeNtIoN De CHuteSEn plus de ce qui précàde, les points évoqués ci-dessous doivent àtre étudiés dans le cadre d’untravail avec des patients dans un programme de preévention de chute.

1. L’utilisation du harnais de soutieu est recommendé lors de l’entraànement et de l ‘évaluation de la stabilité.

NOTA: Le harnais ne sert qu’à aider le patient à atteindre le déficit de stabilité. Le harnais seul ne peut pas prévenir des chutes.

2. Puisque le sysàme de stabilité permet une inclinaison de 20º, démarrer avec une stabilité 8 et avancer en fonction de la tolérance rencontrée.

NOTA: Le niveau 8 est le niveau le plus stable et le niveau l est le niveau le moins stable les deux réglages permettent 20ºd’inclinaison.

3. Des patients particuliérement faibles ou atrophiées surtout dans les extrémités infériures doivent àtre surveillées de präs.

NOTA: La cheville fournit une source capitale d’informatioons sensorielles particuliérement importantes pour les personnes Égées.

4. Des séances répétées d’entraânement de stabilité dans lesquelles l’articulation se déplace proche de ses limites entraånent une augmentation de la tonalité musculaire, une sensibilité améliorée et des réponses somato-sensorielles plus vives.

CONTENTS

— 4-3 — CLINICAL CONSIDERATIONS

oRtHoPeDIC aND SPoRtS MeDICINe1. Bilateral Balance Activities• Select desired training mode• Begin at level 12 or static and progress as tolerated• Begin with handrails in the upright position and progress to lowering them• Move platform as per training protocol• Use ball toss drill to increase eye/hand coordination

2. Unilateral Balance Activities• Select desired training mode• Begin at level 12 or static and progress as tolerated• Begin with handrails in the upright position and progress to lowering them• Move platform as per training protocol

3. Bilateral Upper Extremity Activities• Place both hands in a north/south, east/west and diagonal position• Select desired training mode• Begin with a stable platform and progress accordingly• Move platform as per training protocol• Begin on knees and progress to toes, to one knee, to one foot• Progress to unilateral balance, palm centered on the platform

Fall PReVeNtIoN1. Bilateral Exercises• Begin with static level weight shifts• Progress to dynamic level (12) weight shifts• Use circular grid to demonstrate where tendency to fall occurs• Have patient perform both anterior/posterior and medial/lateral exercises

2. Unilateral Exercises• Have patient hold platform steady and illustrate how well the patient holds the platform stable• Different patterns (circles, anterior/posterior, medial/lateral) to increase strength of the

lower extremity

3. Fall Risk Assessment Testing

4. CTSIB Testing

ReFeReNCe NoteS1. Caution must be noted when performing this activity. Ensure that the patient has the ability

to handle this challenging activity.

2. Ensure proper bilateral stabilization prior to unilateral stabilization.

3. Ensure that patient uses the handrails as needed.

4. Ensure that bilateral and unilateral static stability are adequate prior to progressing to unilateral dynamic stability.

5. The more unstable the platform (12 vs. one) the more challenging the activity will become.Ensure the patient uses the handrails at all times.

5. APPLICATIONS

— 5-1 — APPLICATIONS

Note De RéFéReNCe1. Cette activité doit àtre entreprise avec précaution. S’assurer que le patient est capable de

réaliser l’activité.

2. S’assurer d’une bonne stabilité bilatérale avant de commencer un travail sur la stabilité unilatérale.

3. S’assurer que le patient sait utiliser l’appui correctement.

4. S’assurer que la stabilité bilatérale statique sur une seule jambe est adéquate avant de procéder à la stabilité unilaterérale.

5. Plus le plateau est instable (8 équivaut à un réglage plus stable, le réglage l équivaut à un niveau moins stable), plus l’activité est difficile ä réaliser. S’assurer que la patient utilise l’appui à tout moment.

5. APPLICATIONS

APPLICATIONS — 5-2 —

The Biodex Balance System software program is easy to master. Simply follow the screen promptsas they lead you step-by-step through testing and training protocols or software utility options.For each screen, active option keys are highlighted in boldface type. Touch the desired on-screenkey to make your selection. Option choices progress logically based on the selections made.

There is no more on/off button. There is always power to the display. The screen saver goes blankafter a time out period. System default is 5 minutes. This can be adjusted in System Utilities. Seepage 11-1.

When the screen is dark and the unit is plugged into wall current, just touch the screen and thelast viewed screen will be presented.

SCReeN KeYSThe following on-screen touch keys are consistent whenever they appear throughout the entireBalance System SD program.

<HOME>: Touch this key to return to the Main Menu.<NEXT>: Touch this key to advance to the next logical screen.<BACK>: Touch this key to return to the previous screen.<OK>: Touch this key to confirm selections or entries and advance to the next screen.

Figure 6.1. The Balance System Main Menu.

6. GETTING STARTED

— 6-1 — GETTING STARTED

The training modes provide a simple means of setting up a training or exercise session. Sixinteractive game-like training modes are provided. These allow for fast patient setups, less for-mal protocols than the testing routines, and the ability to change stability level from very unsta-ble to static during the actual training session. All six training modes can be customized to pro-vide specific rehab goals with the on-screen grid and score-keeping functions used to both helpmotivate users and keep them focused on the task at hand.

In training mode, only the most basic parameters are addressed. If desired, a pre-existingpatient can be recalled from the Test/Rehab Results option in Patient Maintenance menu toallow for quick and easy repeat of a training or test session. The print screen function will allowthe user to generate a printout of training results.

Training results can also be saved and recalled for later use by touching the <Save> icon on theresults screen following any training session. A patient name is required to save the results. Ifno pre-existing name is available, the name entry screen will be displayed. Fill out the patientinformation and touch <Save> to record the training result numeric values, along with patientfoot position on the platform.

To recall a patient and repeat an exercise session, select the desired patient from the PatientManagement screen (see chapter 11, System Utilities) and touch <Repeat>. The Position Patientscreen with previous values is presented so the patient can be easily repositioned exactly as inthe previous training session.

Training mode formats include: postural stability, limits of stability, weight shift, maze control,random control and percent weight bearing training as described in the following sections.

Figure 7.1. The Training Menu screen provides access to the Postural Stability, Limits of Stability,Weight Shift, Maze Control, % Weight Bearing and Random Control training modes.

7. THE TRAINING MODES

— 7-1 — THE TRAINING MODES

PoStuRal StaBIlItY tRaINING (See Figure 7.2.)

The Postural Stability Training mode is designed to emphasize specific movement patterns orstrategies by placing markers anywhere on the screen grid. The patient’s score is a tally of howmany times the patient can touch targets with the on-screen cursor during any session. Timecounts up or down as set.

Figure 7-2. The Postural Stability Training screen.

to access the Postural Stability Mode:

1. Position the support handles as per patient protocol.

2. Position the display height and tilt for patient comfort.

3. At the Main Menu, touch <Training>. The Training Menu screen should now be displayed.

4. Touch <Postural Stability>. The User Setup Information screen should now be displayed. Ifthis is a new patient and you want to save this training session after its completion, youmust enter the patient’s name, height and weight. If you do not need to save the trainingsession, touch <Next> and skip to step 8.

5. Touch the <Keypad> icon for “Name” and enter the patient’s name. Touch <OK> to returnto the User Information screen.

6. Touch the <Keypad> icon for “Age” and enter the patient’s age. Touch <OK> to return tothe User Information screen.

7. Touch the <Keypad> icon for “Height” and enter the patient’s height. Touch <Next> toadvance to the Postural Stability Training screen.

8. At the Postural Stability Training screen, touch <Place Target> and then touch the screenlocation where you would like a target to be placed. Repeat this process to place up to ninetargets on the screen.

7. THE TRAINING ROUTINE

THE TRAINING MODES — 7-2 —

9. To clear any misplaced or unwanted targets, touch <Clear Target>. Each time this key ispressed, the most recent target added to the screen will be removed.

10. Touch <More Options> to advance to the Postural Stability Training Options screen ifdesired. Here you can set the total time for the exercise, enter initial and ending platformstability settings, and turn tracing ON/OFF. Touch <OK> to confirm your selections andreturn to the Postural Stability Training Options screen, or <Cancel> to return to thePostural Stability Training Options screen without making changes.

• Use the <�> or <�> keys to set the total time in 10-second increments (during the routine the system will count down from the time setting selected).

NOTE: Total time must be set before you can set beginning and ending platform stability.

• To set initial platform stability, touch the appropriate key and then enter the setting from the keypad displayed (static, 12 is most stable, 1 is least stable). Touch <OK> to return to the Postural Stability Training Options screen and set the ending platform stability in the same manner.

• To turn tracing ON/OFF, touch <Tracing> to toggle between choices.

11. At the Postural Stability Training screen touch the <�> or <�> keys to select the desiredplatform stability if not already selected (static, 12 is most stable, 1 is least stable).

12. Explain the training protocol to the patient and then press <Start> on the display to begin thetraining session. The Stability Training grid on the screen charts the patient’s stability per-formance through the course of the training session (touch the <Magnifying Glass> to enlargethe screen if desired). The Elapsed Time from the start of the training session is shown at thetop right of the display while the stability level is illustrated by a bar graph in the upper right-hand corner. Note that the stability level of the foot platform can be changed at any time dur-ing the exercise session.

NOTE: If you have selected to enlarge the screen by touching the <Magnifying Glass>, you mustreturn to the normal viewing screen format to make any changes.

NOTE: As the patient moves the platform during the training session, a "tracing" feature recordsthe route of the cursor on the grid. This feature can be used to visually illustrate a patient’s position-ing throughout the routine, or as a target, i.e., asking the patient to "trace" a letter, square, circle,etc.

13. At any time during the training session, the "tracing" can be erased by pressing <ClearTracing>.

14. To stop the training session at any time, press <Stop> on the display. The system will stopgathering data and the platform will advance to the locked position.

15. When you are finished reviewing the training screen, touch <Print> to print the screen, or <Save Results> to save the training session (numeric data only).

16. After printing or reviewing the screen, press <Start> to immediately begin another trainingsession using the same parameters, or press <Back> to return to the Training Setup screen.

CONTENTS


lIMItS oF StaBIlItY (loS) tRaINING RoutINe(See Figure 7.3.)

The Limits of Stability Training screen is designed to challenge the user to move through amovement pattern consistent with the sway envelope. The sway envelope is that area a personcan move their COG within their base of support. It is approximated from vertical as 8 degreesto one side, 8 degrees to the other (total of 16 degrees of sway,) and 8 degrees forward and 4degrees back (12 degrees total). Limits of Stability training and testing are based on challengingthe patient within this sway envelope. Testing is usually done at 75% LOS, which is the moder-ate skill level. Easy skill level is 50% and hard skill level is 100% of the sway envelop.

Scoring percentage-based and reflects the directional accuracy of the movement to the blinking targets (see Appendix B-1) time counts up.

Figure 7.3. The Limits of Stability (LOS) Training Screen.

to access the limits of Stability training Mode:




4. Touch <Limits of Stability>. The User Setup Information screen should now be displayed.If this is a new patient and you want to save this training session after its completion, youmust enter the patient’s name, height and weight. If you do not need to save the trainingsession, touch <Next> and skip to step 8.



CONTENTS


7. Touch the <Keypad> icon for “Height” and enter the patient’s height. Touch <Next> toadvance to the Limits of Stability Training screen.

8. At the Limits of Stability Training screen, touch <Stance> to toggle though the patientstance positions until the desired choice, right leg, left leg or both legs, is displayed.

9. Touch <Skill Level> to tighten or widen the spread between targets. Three skill levels areavailable from which to choose. Touch <Skill Level> until the desired target configuration isdisplayed.

10. If desired, touch <Clear Tracing> to remove any tracing that remains on the screen from aprevious exercise session.

11. Touch <More Options> to advance to the Limits of Stability Training Options screen ifdesired. Here you can set the Limits of Stability Hold Time for the exercise and turn TracingON/OFF. Touch <OK> to confirm your selections and return to the Limits of Stabilityscreen, or <Cancel> to return to the Limits of Stability screen without making changes.

• To set a Limits of Stability Hold Time, use the <�> or <�> keys to scroll to the desiredsetting. Hold times range from .025 to 5 seconds.


12. At the Limits of Stability Training screen touch the <�> or <�> keys to select the desiredplatform stability (static, 12 is most stable, 1 is least stable).

13. Explain the training protocol to the patient, then press <Start> to begin the LOS training ses-sion. The LOS Training screen reflects the patient’s stability performance through the courseof the LOS training session. The Elapsed Time from the start of the training session is shownat the top right of the display while the stability level is illustrated by a bar graph. A run-ning patient score is also provided in the upper right corner. Note that the stability level ofthe foot platform can be changed at any time during the exercise session.




16. When you are finished reviewing the training screen, touch <Print> to print the screen, or <Save Results> to save the training session (numeric data only).


8. TESTING A PATIENT


WeIGHt SHIFt tRaINING(See Figure 7.4)

This training mode allows for exercise in the most basic of activities weight shifting. The patienthas the ability to shift weight in medial/lateral, anterior/posterior and diagonal planes. This canbe done with both static and dynamic settings. During this training routine the target zone,defined by two parallel lines, can be rotated to any of three positions while the amount of excur-sion within the target area can be modified to allow for the most limited to most difficult degreeof weight shifting. To reposition the target zone hit lines at any time, simply touch the desiredline and re-touch the screen where you want the line to be relocated.

Scoring is percentage-based and equals net good hits/total target hits. If you cross the bound-ary, that counts against the good hit total. All outside boundary hits are subtracted from thetotal amount of target hits. This value equals the net good hits.

For example: Enter 10 as the # of target hits. There were 4 times the cursor went outside theboundary. 10-4 = 6 good hits. Score = 6/10 or 60%.

For weight shift training the time value always counts up.

NOTE: A wall hit is counted as one hit within the path to the target hit.

Figure 7.4. The Weight Shift Training Screen.

to access the Weight Shift training Mode:




4. Touch <Weight Shift >. The User Setup Information screen should now be displayed. If thisis a new patient and you want to save this training session after its completion, you mustenter the patient’s name, height and weight. If you do not need to save the training session,touch <Next> and skip to step 8.

CONTENTS


target zone hit



7. Touch the <Keypad> icon for “Height” and enter the patient’s height. Touch <Next> toadvance to the Weight Shift Training screen.

8. At the Weight Shift Training screen, touch <Rotate Target > to toggle through the threepatient target positions until the desired rotation is displayed on the grid.

9. Touch <Skill Level> to enlarge or decrease the target box size. Three skill levels are availablefrom which to choose. Touch <Skill Level> until the desired target configuration is displayed.


11. Touch <More Options> to advance to the Weight Shift Training Options screen if desired. Hereyou can set the total hits for the exercise (default = 60), set platform stability and turn tracingON/OFF. Touch <OK> to confirm your selections and return to the Weight Shift TrainingOptions screen, or <Cancel> to return to the Weight Shift Training Options screen withoutmaking changes.

• Use the <�> or <�> keys to set the total hits.

NOTE: Total hits must be set before you can set beginning and ending platform stability.

• To set initial platform stability, touch the appropriate key and then enter the setting fromthe keypad displayed (static, 12 is most stable, 1 is least stable). Touch <OK> to return tothe Weight Shift Training Options screen and set the ending platform stability in the samemanner.


12. At the Weight Shift Training screen touch the <�> or <�> keys to select the desired plat-form stability if not already selected (static, 12 is most stable, 1 is least stable).

13. Explain the training protocol to the patient and then press <Start> on the display to begin thetraining session. The Stability Training grid on the screen charts the patient’s stability per-formance through the course of the training session (touch the <Magnifying Glass> to enlargethe screen if desired). The Elapsed Time from the start of the training session is shown at thetop right of the display while the stability level is illustrated by a bar graph in the upper rightcorner. A running patient score is also provided in the upper right corner. Note that the stabil-ity level of the foot platform can be changed at any time during the exercise session.


14. At any time during the training session, the "tracing" can be erased by pressing <Clear Tracing>.


16. When you are finished reviewing the Weight Shift Training screen, touch <Print> to printthe screen, or <Save Results> to save the training session (numeric data only).


CONTENTS


MaZe CoNtRol tRaINING (See Figure 7.5.)

This mode allows the patient to follow a reproducible pattern of movement throughout a mazein both static and dynamic environments. Three skill levels allow the maze to be modified tocreate a simple or more difficult environment for the patient to navigate through. Change theplatform from static mode to dynamic mode to facilitate progression. Time counts up or downas set.

Scoring is percentage-based on the net good hits/total target hits. If the cursor hits the boundarythat hit is subtracted from the total possible amount of good hits.

• Easiest maze has 28 total targets, 14 in each direction• Moderate has 36 targets, 18 in each direction• Most difficult has 72 targets, 36 in each direction

In the case of the easiest maze. If the wall is hit 6 times the resulting score will be 22/28 = 78%

Figure 7.5. The Maze Control Training screen.

to access the Maze Control Mode:




4. Touch <Maze Control >. The User Setup Information screen should now be displayed. Ifthis is a new patient and you want to save this training session after its completion, youmust enter the patient’s name, height and weight. If you do not need to save the trainingsession, touch <Next> and skip to step 8.

CONTENTS




7. Touch the <Keypad> icon for “Height” and enter the patient’s height. Touch <Next> toadvance to the Maze Control Training screen.

8. Touch <Skill Level> to increase or decrease the number of targets displayed on the graph.Three skill levels are available from which to choose. Touch <Skill Level> until the desiredtarget configuration is displayed.


10. Touch <More Options> to advance to the Maze Control Training Options screen if desired.Here you can set the total time for the exercise, enter initial and ending platform stabilitysettings, change sensitivity, and turn tracing ON/OFF. Touch <OK> to confirm your selec-tions and return to the Maze Control Training Options screen, or <Cancel> to return to theMaze Control Training Options screen without making changes.

Figure 7.5a. The Maze Control Training Options screen.

• Use the <�> or <�> keys to set the total hits.

Increase Cursor Sensitivity• Some patients may find it difficult to move their center of gravity to reach objects in the

boundary areas of the field of play. This can often be compensated for by selecting a shorter height for the patient. In the case of the Maze or Random control training, the ability to increase the cursor sensitivity even more was added.


CONTENTS


• To set initial platform stability, touch the appropriate key and then enter the setting from the keypad displayed (static, 12 is most stable, 1 is least stable). Touch <OK> toreturn to the Maze Control Training Options screen and set the ending platform stabili-

tyin the same manner.


11. At the Maze Control Training screen touch the <�> or <�> keys to select the desired plat-form stability if not already selected (static, 12 is most stable, 1 is least stable).

12. Explain the training protocol to the patient and then press <Start> on the display to beginthe training session. The Stability Training grid on the screen charts the patient’s stabilityperformance through the course of the training session (touch the <Magnifying Glass> toenlarge the screen if desired). The Elapsed Time from the start of the training session isshown at the top right of the display while the stability level is illustrated by a bar graph inthe upper right corner. A running patient score is also provided in the upper right corner.Note that the stability level of the foot platform can be changed at any time during the exer-cise session.




15. When you are finished reviewing the Maze Control Training screen, touch <Print> to printthe screen, or <Save Results> to save the training session (numeric data only).


CONTENTS


tHe RaNDoM CoNtRol tRaINING

This training mode allows the patient to perform neuromuscular control activities in random pat-terns generated by the display and is ideal for motor control and vestibular training. The size andspeed of the target can be modified for progressions ranging from easy to difficult. While in staticmode the patient can work within their sway envelope to move the cursor and attempt to keep itwithin the moving target. In dynamic mode the patient must utilize various hip, knee and anklestrategies to manipulate the moving platform's cursor to within the random moving target.

Scoring is percentage-based and equals the total time inside the circle/total time in and outsideof the circle. Time counts up or down as set.

Figure 7.6. The Random Control Training screen.

to access the Random Control training Mode:




4. Touch <Random Control >. The User Setup Information screen should now be displayed. Ifthis is a new patient and you want to save this training session after its completion, youmust enter the patient’s name, height and weight. If you do not need to save the trainingsession, touch <Next> and skip to step 8.



7. Touch the <Keypad> icon for “Height” and enter the patient’s height. Touch <Next> toadvance to the Random Control Training screen.

CONTENTS


8. At the Random Control Training screen, the target circle should be flashing in the center ofthe stability grid. Touch <Circle Speed > to toggle though the three target circle speeds untilthe target circle flashes at the desired speed.

9. Touch <Skill Level> to enlarge or decrease the target circle size. Three skill levels are avail-able from which to choose. Touch <Skill Level> until the desired target size is displayed.


11. Touch <More Options> to advance to the Random Control Training Options screen ifdesired. Here you can set the total time for the exercise, enter initial and ending platformstability settings, and turn tracing ON/OFF. Touch <OK> to confirm your selections andreturn to the Random Control Training Options screen, or <Cancel> to return to theRandom Control Training Options screen without making changes.

• Use the <�> or <�> keys to set the total time in 10-second increments (during the routine the system will count down from the time setting selected).


• To set initial platform stability, touch the appropriate key and then enter the setting from the keypad displayed (static, 12 is most stable, 1 is least stable). Touch <OK> to return to the Random Control Training Options screen and set the ending platform stability in the same manner.


12. At the Random Control Training screen touch the <�> or <�> keys to select the desiredplatform stability if not already selected (static, 12 is most stable, 1 is least stable).

13. Explain the training protocol to the patient and then press <Start> on the display to begin thetraining session. The Stability Training grid on the screen charts the patient’s stability per-formance through the course of the training session (touch the <Magnifying Glass> to enlargethe screen if desired). The Elapsed Time from the start of the training session is shown at thetop right of the display while the stability level is illustrated by a bar graph in the upper rightcorner. A running patient score is also provided in the upper right corner. Note that the stabil-ity level of the foot platform can be changed at any time during the exercise session.


14. At any time during the training session, the "tracing" can be erased by pressing <Clear Tracing>.


16. When you are finished reviewing the Random Control Training screen, touch <Print> toprint the screen, or <Save Results> to save the training session (numeric data only).


CONTENTS


PeRCeNt WeIGHt-BeaRING tRaINING(See Figures 7.7 and 7.8.)

Percent Weight-Bearing Training provides real-time feedback of the percentage of weight-bear-ing on the patient’s foot, ankle, knee, hip, body side, etc. In this mode targets can be set thatencourage patients to focus on % weight-bearing goals in anterior, posterior, medial and lateralmovements. Therapists and patients should find % weight-bearing training to be an effectivemode for communicating what, where and how a patient’s body weight is located or feels.

Figure 7.7. The Percent Weight-Bearing Training screen.

NOTE: Scoring is the percent time spent within the target range. The axis will show green when weightbearing is within target settings.

If desired, shift the red Percent Weight Bearing target zone by touching and dragging the appropriate red line to the desired Percent Weight Bearing target.

Figure 7.8. If desired, use the More Options button to set the training grid to medial lateral only.

CONTENTS


to access the % Weight-Bearing training Mode:

NOTE: % Weight-Bearing is used with the platform in static mode only.


2. Position the display height and position for patient comfort.


4. Touch <% Weight Bearing>. The User Setup Information screen should now be displayed. Ifthis is a new patient and you want to save this training session after its completion, youmust enter the patient’s name, height and weight. If you do not need to save the trainingsession, touch <Next> and skip to step 8.

5. Touch the <Keypad> icon for “Name” and enter the patient’s name. Touch <OK> to returnto the User Setup Information screen.

6. Touch the <Keypad> icon for “Age” and enter the patient’s age. Touch <OK> to the returnto the User Setup Information screen.

7. Touch the <Keypad> icon for “Height” and enter the patient’s height. Touch <Next> toadvance to the Position Patient screen.

8. Position the patient on the system and explain the training protocol. Press <Start> on thedisplay to activate the cursor and have the patient move the cursor to the center point onthe grid.

9. Touch <Record> to bring up the Position Patient Entry screen. Using the keypads, enter thepatient’s left foot, left heel, right foot and right heel positions using the midline of the footand the platform grid as reference points. Touch <Next> to advance to the % WeightBearing Training screen.

10. The % Weight Bearing Training screen displays a Medial Lateral/Anterior Posterior grid. Ifyou would prefer a Medial Lateral only grid, touch <More Options>. The More Optionsscreen also allows the clinician to set an end by time value. Touch <OK> after makingchanges to return to the % Weight Bearing Training screen.

11. If desired, shift the red % Weight Bearing target zone by touching and dragging the appro-priate red line to the desired % Weight Bearing target.

12. Explain the training protocol to the patient and then press <Start> on the display to beginthe training session. The grid charts the patient’s weight-bearing performance though thecourse of the training session (touch the <Magnifying Glass> to enlarge the screen ifdesired.) The Elapsed Time from the start of the session is shown at the top right of the dis-play. A running patient score is provided in the upper right corner.


13. To stop the training session at any time, press <Stop> on the display. The system will stopgathering data.

CONTENTS


14. When you are finished reviewing the % Weight Bearing Training screen, touch <Print> toprint the screen, or <Save Results> to save the training session (numeric data only).


NOTE: Scoring is the % time spent within the target range.

Create, Save and Recall Custom ProtocolsCustom protocols are organized as those for Training and those for Testing. Creating protocolsare the same for either case.

1. In System Utilities Select <Custom Protocol List >

2. A Custom Protocol list will appear.

3. Select <Create Protocol>

CONTENTS


4. Select Training or Testing. Protocol creation is same for both.

5. All target placements and goal settings are saved and recalled for custom protocols.

6. Be sure to name the protocol as the protocol can then be recalled exactly as stored for reuseas a custom protocol.

CONTENTS


Selecting a Custom Protocol

1. To select a previously created custom protocol simply <Select Custom Protocol> from eitherthe Training or Testing menu screen.

2. A listing of either Training or Testing protocols will appear. Select desired protocol.

CONTENTS


The Biodex Balance System SD allows clinicians to assess a patient’s neuromuscular control in aclosed-chain, multi-plane test by quantifying the ability of the patient to maintain dynamic uni-lateral or bilateral postural stability on either a static or unstable surface. The degree of surfaceinstability is controlled by the system’s microprocessor-based actuator. The clinician selects thetest duration, stability level and protocol.

In a dynamic test, once the session beings the patient’s ability to control the platform angle isquantified as a variance from the locked (level) position, as well as degrees of deflection overtime. A large variance may be indicative of poor neuromuscular response. Further insight intospecific neuromuscular activation patterns is realized with the quantification of anterior/poste-rior and medial/lateral platform tilt. Predictive Values and Comparative (Bilateral) Reports areavailable to chart the patient’s performance. Bilateral comparisons quickly document differencesbetween each lower extremity.

Static testing measures the angular excursion of the patient's center of gravity. Body height mustcome into play for static measures. A person's Center of Gravity (COG) is approximately 55% oftheir height. Based on the selected height an appropriate static measure scaling is applied.Testing in this mode is ideal for baseline testing for movement disorder, vestibular dysfunctionand orthopedic patients. Good static testing scores can lead to a progression into dynamic test-ing and training.

Test formats include Postural Stability, Limits of Stability, Athlete Single Leg, CTSIB and FallRisk. Postural Stability and Limits of Stability testing are available at variable levels of difficulty.Bilateral reports (comparsion of postural stability performance of standing on one leg versusstanding on the other) are available in More Options of Postural stability testing.

As with training, patients with saved tests can be recalled for easy positioning from the PatientManagement screen by selecting the desired patient record and touching <Repeat>. See Chapter 11.

Figure 8.1. The Testing Menu screen.

8. TESTING

— 8-1 — TESTING

tHe PoStuRal StaBlItIY teSt

The Postural Stability Test emphasizes a patient’s ability to maintain center of balance. Thepatient’s score on this test assesses deviations from center, thus a lower score is more desirablethan a higher score.

Platform stability can be varied during a this test by selecting <More Options> from thePostural Stability Testing screen. Clinicians can also set trial time, number of trials, starting andending platform stability, rest countdowns or bilateral test.

Figure 8.2. The Patient Position screen with patient positions entered.

Figure 8.3. The Postural Stability Testing Options screen.

CONTENTS

TESTING — 8-2 —

Figure 8.4. The Postural Stability Testing screen.

Figure 8.5. A sample Postural Stability Test Results screen for a bilateral test.

CONTENTS

— 8-3 — TESTING

PeRFoRMING a PoStuRal StaBIlItY teSt(See Figures 8.2 and 8.6.)

1. Position support handles as per patient protocol.

2. Position display height and tilt for patient comfort.

3. At the Main Menu, touch <Testing>. The Testing Menu screen should now be displayed.

4. Touch <Postural Stability>. The User Setup Information screen should now be displayed.

5. Touch the <Keypad> icon for "Name" and enter the patient’s name. Touch <OK> to returnto the User Setup Information screen.

6. Touch the <Keypad> icon for "Age" and then enter the patient’s age. Touch <OK> to returnto the User Setup Information screen.

7. Touch the appropriate <Height> key to highlight the patient height range setting desired.Touch <Next> to advance to the Patient Position screen.

8. Position the patient on the system and explain the test protocol. Press <Start> on the displayto activate the cursor and have the patient move the cursor to the center point on the grid.

9. Touch <Record> to bring up the Position Patient Entry screen. Using the keypads, enter thepatient’s left foot, left heel, right foot and right heel positions using the midline of the footand the platform grid as reference points. Touch <Next> to advance to the Postural StabilityTesting screen.

10. At the Postural Stability Testing screen, touch <Stance> to scroll through the three stancepositions provided: left, right or both.

11. Touch <Tracing> to toggle tracing ON or OFF as desired.

12. Touch <Clear Tracing> to clear any tracing that remains from previous tests.

13. Touch <More Options> to advance to the Postural Stability Test Options screen if desired.Here you can set the Test Trial Time, enter initial and ending platform stability settings,enter the number of trials, enter the Rest Countdown, or toggle bilateral comparison to"Yes" or "No" and enter the Rest Countdown. You can also toggle the cursor ON/OFF.Touch <OK> to confirm your selections and return to the Postural Stability Testing screen.

• Use the <�> or <�> keys to set the total time in five-second increments (during the routine the system will count down from the time setting selected).


• To set initial or ending platform stability (static, 12 is most stable, 1 is least stable,) touchthe appropriate key and then enter the setting from the keypad displayed. Touch <OK> toreturn to the Postural Stability Testing Options screen and set the ending platform stabilityin the same manner.

• To set the number of trials or rest countdown, touch the appropriate key and then enter the setting from the keypad displayed.

• To turn the cursor ON/OFF, touch <Cursor> to toggle between choices.

• To toggle bilateral comparison "Yes" or "No," touch <Bilateral Comparison>.

CONTENTS

TESTING — 8-4 —

14. Press <Start> to release the platform (if not static) and activate the Postural Stability Testscreen.

15. With the patient ready to begin the test, touch <Collect Data>. The screen will provide a three-second countdown before beginning the first of three test trials. The display screen will showTotal Trial Time, Platform Setting and Stance to the left of the grid. Trial Number and scoreare displayed to the right of the grid. If desired, at this point you can touch the <MagnifyingGlass> to select the zoom feature. You must, however, leave the zoom feature to make anychanges.

NOTE: To stop a test in progress at any time and return to the Postural Stability Testing screenwith the platform locked, touch <Cancel> or <Stop>.

16. When the first trial is finished, the screen will display "Trial 1 Complete," the platform willreturn to the locked position, and a 10-second rest countdown will begin for the secondtrial. Touch <Collect Data> to begin the second test trial and continue in the same manner tocomplete trials two and three.

17. After completing the test, a "Test Complete" message is displayed. Touch <Results> toadvance to the Postural Stability Test Results screen.

NOTE: If you have selected Bilateral Test, the system will begin by testing the initial side as set upabove. After the third trial on the initial side is finished, touch <Test Other Leg> to continue. Thesystem automatically selects the opposite side and then allows the user to proceed from the PositionPatient screen. Repeat steps 8 – 17 to test the opposite side.

18. At the Postural Stability Test Results screen, touch <Print> to automatically generate a print-ed report if desired. If you have performed a Bilateral Test, the Test Results screen andreport will provide a bilateral comparison.

19. To save the test data, touch <Save Results> and then touch <OK> in response to the "SaveResults for later reporting or export?" prompt. The system will display "Save ResultsCompleted after the results are saved.

20. To return to the Opening Menu from the Postural Stability Test Results screen touch <Home>.

CONTENTS

— 8-5 — TESTING

SuGGeSteD teSt PRotoCol FoR GeNeRal PoStuRal StaBIlItY BalaNCe teStING

The test protocol most commonly used with the Biodex Balance System is a Dynamic Balancetest as follows:

Test Duration: 20 secondsStability Level: 8Stance: Two Leg

Reliability studies have been done for this protocol. In addition, much of the research being pre-sented is at these levels. Three or four trial repetitions should be performed prior to testing ateach level. Again, this is supported by research.

The patient’s performance is noted as a stability index. The stability index represents the vari-ance of platform displacement in degrees from level. A high number is indicative of a lot ofmotion, which is indicative of the patient having trouble balancing. Differences between rightand left limbs can be noted.

Orthopedic problems many times present neuromuscular control problems. You will see this bytesting single leg involved and uninvolved. Balance training will improve their control.

Geriatric patients can also be tested for excessive sway. The direction of the sway is importantwith regards to the predisposition of a falls direction. Falling to either side significantly increas-es the chances of a hip fracture.1,2,3

References:1. Cumming, Robert G., Klineburg, Robin J., "Fall Frequency and Characteristics and the Risk ofHip Fractures." JAGS, 42:774-778, 19942. Nevitt, Michael C., Cummings, Steven R., Hudes, Estie, "Risk Factors for Injurious Falls: AProspective Study." Journal of Gerontology: Medical Sciences. 46:5, M164-170, 1991.3. This information was presented in abstract form at the New England Chapter of the AmericanCollege of Sports Medicine Thursday October 1, 1998. It is titled Stability PerformanceAssessment Among Subject of Disparate Balancing Abilities. J.A. Finn, M.M. Alvarez, R.E. Jett,D.S. Axtell, D.D. Kemler, Exercise Science Department, Southern Connecticut State University,New Haven, CT.

9. THE BALANCE REPORTS

TESTING — 8-6 —

tHe lIMItS oF StaBlItIY (loS) teSt

This test challenges patients to move and control their center of gravity within their base of sup-port. During each test trial, patients must shift their weight to move the cursor from the centertarget to a blinking target and back as quickly and with as little deviation as possible. The sameprocess is repeated for each of nine targets. Targets on the screen blink in random order. Threeskill levels allow the targets to be grouped closer together or spread further apart. If desired,single leg LOS test may be performed but no bilateral comparison is provided.

This test is a good indicator of dynamic control within a normalized sway envelope. Poor con-trol, inconsistencies or increased times suggests further assessment for lower extremity strength,proprioception, vestibular or visual deficiencies may be indicated. The default setting for theLOS test is 75% LOS (moderate still level).

References:1. Clark S, Rose DJ, Fujimoto K. Generalizability of the Limits of Stability Test in The Evaluationof Dynamic Balance Among Older Adults. Arch Phys Med Rehabilitation, Vol 78, Oct 1997.

Figure 8.6. The Limits of Stability Testing screen.

Figure 8.7. The Limits of Stability Testing Options screen.

CONTENTS

— 8-7 — TESTING

Figure 8.8. The Limits of Stability Test Results screen for a bilateral test.

PeRFoRMNIG a lIMItS oF StaBIlItY teSt(See Figures 8.7 and 8.9.)




4. Touch <Limits of Stability>. The User Setup Information screen should now be displayed.





9. Touch <Record> to bring up the Position Patient Entry screen. Using the keypads, enter thepatient’s left foot, left heel, right foot and right heel positions using the midline of the footand the platform grid as reference points. Touch <Next> to advance to the Limits ofStability Testing screen.

10. At the Limits of Stability Testing screen, touch <Stance> to scroll through the three stancepositions provided: left, right or both.


CONTENTS

TESTING — 8-8 —


13. Touch <More Options> to advance to the Limits of Stability Test Options screen if desired.Here you can set the number of trials, rest countdown, platform stability and limits of stabil-ity hold time. You can also toggle the cursor ON/OFF. Touch <OK> to confirm your selec-tions and return to the Limits of Stability Testing screen.

• Use the <�> or <�> keys to set the Limits of Stability Hold Time.


• To set number of trials, rest countdown or platform stability (static, 12 is most stable, 1 is least stable,) touch the appropriate key and then enter the setting from the keypad displayed.

14. Press <Start> to release the platform (if not static) and activate the Limits of Stability Testscreen.

15. With the patient ready to begin the test, touch <Collect Data>. The screen will provide athree-second countdown before beginning the first of three test trials. The display screenwill show Test Trial Time, Platform Setting and Stance to the left of the grid. Trial Numberand score are displayed to the right of the grid.

NOTE: To stop a test in progress at any time and return to the Limits of Stability Testing screenwith the platform locked, touch <Cancel> or <Stop>.


17. After completing the test, a "Test Complete" message is displayed. Touch <Results> toadvance to the Limits of Stability Test Results screen.

18. At the Limits of Stability Test Results screen, touch <Print> to automatically generate aprinted report if desired. If you have performed a Bilateral Test, the Test Results screen andreport will provide a bilateral comparison.


20. To return to the Opening Menu from the Limits of Stability Test Results screen touch<Home>.

CONTENTS

— 8-9 — TESTING

atHlete SINGle leG StaBIlItY teStING

The test protocol for the Athlete Single Leg Stability Testing allows clinicians to test athletesagainst data derived from studies using the Biodex Balance System. The low stability level offour will challenge athletes and provide the data necessary to assess the athlete’s single leg pos-tural stability.

Figure 8.9. The Athlete Single Leg Stability Testing screen.

Figure 8.10. The Athlete Single Leg Stability Testing Options screen.

CONTENTS

TESTING — 8-10 —

Figure 8.11. A sample Athlete Single Leg Stability Results report.

CONTENTS

— 8-11 — TESTING

PeRFoRMING aN atHlete SINGle leG StaBIlItY teSt(See Figures 8.10 - 8.12.)




4. Touch <Athlete Single Leg Stability >. The User Setup Information screen should now be displayed.





9. Touch <Record> to bring up the Position Patient Entry screen. Using the keypads, enter thepatient’s left foot, left heel, right foot and right heel positions using the midline of the footand the platform grid as reference points. Touch <Next> to advance to the Athlete SingleLeg Stability Testing screen.

10. At the Athlete Single Leg Stability Testing screen, touch <Stance> to toggle between left andright leg positioning.



13. Touch <More Options> to advance to the More Options screen if desired. Here you can setthe Test Trial Time, enter initial and ending platform stability settings, enter the number oftrials and enter the Rest Countdown. You can also toggle the cursor ON/OFF. Touch <OK>or confirm your selections and return to the Athlete Single Leg testing screen.

• Use the <�> or <�> keys to set the total time in five-second increments (during the routine the system will count down from the time setting selected).


• To set initial or ending platform stability (static, 12 is most stable, 1 is least stable,) touch the appropriate key and then enter the setting from the keypad displayed. Touch <OK> to return to the Athlete Single Leg Stability Testing Options screen and set the ending platform stability in the same manner.



CONTENTS


14. Press <Start> to release the platform (if not static) and activate the Limits of Stability Testscreen.

15. With the patient ready to begin the test, touch <Collect Data>. The screen will provide athree-second countdown before beginning the first of three test trials. The display screenwill show Test Trial Time, Platform Setting and Stance to the left of the grid. Trial Numberand score are displayed to the right of the grid.

NOTE: To stop a test in progress at any time and return to the Athlete Single Leg Stability Testingscreen with the platform locked, touch <Cancel> or <Stop>.


17. After completing the test, a "Test Complete" message is displayed. Touch <Results> toadvance to the Athlete Single Leg Stability Test Results screen.

18. At the Athlete Single Leg Stability Test Results screen, touch <Print> to automatically gener-ate a printed report if desired.


20. To return to the Opening Menu from the Athlete Single Leg Stability Test Results screentouch <Home>.

teSt PRotoCol FoR atHlete SINGle leG StaBIlItY teStING

This test protocol can be used to compare patients of similar age ranges in a normative database.

Test Duration: 20 secondsLevel: FourStance Type: Single legTrials: 3

References:Athlete Single Leg Stability Test results compliation of data from:• Paterno MV et al, Neuromuscular Training Improves Single Limb Stability in Young Female

Athletes. J Orthopedic Sports Therapy, June 2004 • Arnold BL, Schmitz R, Examination of Balance Measures Produced by the Biodex Stability

System. J of Athletic Training 1998:33(4):323-327. • Rozzi S et al, Knee Joint Laxity and Neuromuscular Characteristics of Male and Female

Soccer and Basketball Players. American J Sports Medicine, Vol. 27, No 3, 1999.

CONTENTS


PeRFoRMING a Fall RISK teSt

The Fall Risk test allows identification of potential fall candidates. Test results are compared toage dependent normative data1. Scores higher than normative values suggest further assessmentfor lower extremity strength, proprioception, and vestibular or visual deficiencies.

Figure 8.12. The Fall Risk Testing screen.

Figure 8.13. The Fall Risk Testing Options screen.

CONTENTS


Figure 8.14. A sample Fall Risk Test Results screen.

PeRFoRMING a Fall RISK teSt(See Figures 8.13 and 8.15.)




4. Touch <Fall Risk>. The User Setup Information screen should now be displayed.





9. Touch <Record> to bring up the Position Patient Entry screen. Using the keypads, enter thepatient’s left foot, left heel, right foot and right heel positions using the midline of the footand the platform grid as reference points. Touch <Next> to advance to the Fall Risk Testingscreen.

10. At the Fall Risk Testing screen touch <Tracing> to toggle tracing ON or OFF as desired.


CONTENTS


12. Touch <More Options> to advance to the Fall Risk Test Options screen if desired. Here youcan set the Test Trial Time, enter the number of trials and enter the Rest Countdown. Youcan also toggle the cursor ON/OFF. Touch <OK> to confirm your selections and return tothe Fall Risk Testing screen.

• Use the <�> or <�> keys to set the Test Trial time in five-second increments (during the routine the system will count down from the time setting selected).



13. Press <Start> to release the platform (if not static) and activate the Fall Risk Test screen.

14. With the patient ready to begin the test, touch <Collect Data>. The screen will provide athree-second countdown before beginning the first test trial. The display screen will showTest Trial Time and Platform Setting to the left of the grid. Trial Number and score are dis-played to the right of the grid.

NOTE: To stop a test in progress at any time and return to the Fall Risk Testing screen with theplatform locked, touch <Cancel> or <Stop>.

15. When the first trial is finished, the screen will display "Trial 1 Complete," the platform willreturn to the locked position, and the rest countdown will begin for the second trial. Touch<Collect Data> to begin the second test trial and continue in the same manner to completetrials two and three.

16. After completing the test, a "Test Complete" message is displayed. Touch <Results> toadvance to the Fall Risk Test Results screen.

17. At the Fall Risk Test Results screen, touch <Print> to automatically generate a printed reportif desired.

18. To save the test data, touch <Save Results> and then touch <OK> in response to the "SaveResults for later reporting or export?" prompt. The system will display "Save ResultsCompleted" after the results are saved.

19. To return to the Opening Menu from the Fall Risk Test Results screen touch <Home>.

10. DATA INTERPRETATION


BalaNCe SYSteM SD PRotoCol FoR Fall RISK BalaNCe teStINGThis test protocol can be used to compare patients of similar age ranges in a normative database.

Test Duration: 20 secondsLevel: 12 to 8Stance Type: Bilateral

A minimum of three test trials should be used to avoid excessive balance deviations.

The patient’s performance is noted as a stability index. Test results are compared to age depend-ent normative data. Scores higher than normative values suggest further assessment for lowerextremity strength, proprioception and vestibular or visual deficiencies. Poor balance is a majorcontributor to falls. Strength, particularly high speed, and proprioceptive training have demon-strated positive results in balance improvement.1

NOTE: For information on normative data referenced in the Predictive Values Report, see Appendix C.

NOTE: For information comparing the original Balance System Protocol for Fall Risk Balance Testing tothe Balance System SD Protocol for Fall Risk Balance Testing, see note and chart page B-1.

References:1. Finn JA, et al, Biodex Balance System Assessment Amoung Subjects of Disparate BalancingAbilities. Presented at the 1999 American College of Sports Medicine Meeting

Updated May 2010

CONTENTS


ClINICal teSt oF SeNSoRY INteGRatIoN aND BalaNCe – CtSIB oR m-CtSIB (MoDIFIeD CtSIB)

The Clinical Test of Sensory Interaction and Balance (CTSIB) is standardized test for Balance assess-ment on a static surface. The CTSIB test protocol is well documented in the literature as an effectivetest for identifying individuals with mild to severe balance problems. The CTSIB consists of six con-ditions. The test provides a generalized assessment of how well a patient can integrate various sens-es with respect to balance and compensate when one or more of those senses are compromised.

• Condition 1 – Eyes open firm surface: Baseline: Incorporates visual, vestibular and somatosensory inputs

• Condition 2 – Eyes closed firm surface: Eliminate visual input to evaluate vestibular and somatosensory inputs.

• Condition 3 – Visual conflict on firm surface: Some vision present but information conflicts with vestibular information. This condition brings in more vestibular and somatosensory inputs.

• Condition 4 – Eyes open on a dynamic surface used to evaluate somatosensory interaction with visually input.

• Condition 5 – Eyes closed on dynamic surface: used to evaluate somatosensory interaction with vestibular input

• Condition 6 – Visual conflict on dynamic surface: Used to evaluate the mediation of visual with and vestibular and somatosensory inputs.

Another version of this test called the modified CTSIB is often used. The m-CTSIB eliminatesconditions 3 and 6. Biodex Balance products use the m-CTSIB format of 4 conditions as thedefault with the ability to include the other 2 if desired.

A note concerning eye glasses for the Visual Conflict condition: Clinicians that want to do the Visual Conflict conditions will require some type of glasses thatprovide a distorted yet transparent image. Commercially available Prism type glasses are com-monly used. Other improvised glasses are: 3D glasses, or clear safety glasses in which the lenseshave been marred or covered with Scotch™ type tape.

What is being measured during the CTSIB test? • Sway Index• Stability Index

The Sway Index is really the Standard deviation of the Stability index. The higher the Sway Index.The more unsteady the person was during the test. The Sway Index is an objective quantification ofwhat commonly is done with a time-based pass/fail for completing the CTSIB stage in 30 secondswithout falling, or assigning a value of 1 to 4 to characterize the sway. 1= minimal sway, 4 = a fall.

The Stability Index is the average position from center. The Stability index does not indicatehow much the patient swayed only their position. Consider the following example.

If a patient is positioned in a manner that biases their placement from the center, the stabilityindex will be a large value. However if they swayed very little the standard deviation would below. This is evident when you see the COG plots. A patient could have a score of 6.5, yet theirstandard deviation would only be .8. The printout tracing will show they did not sway verymuch. However, if they were positioned off-center, or even on center– and they swayed a lotthe standard deviation would be higher. Thus the standard deviation is indicative of sway.

If a patient cannot complete a condition, it is noted as "Fell" on results screen and report.

Specific information on Stability index can be found in Appendix A2.

NOTE: A standardized indexed foam pad that matches the size of the Balance SD platform is provided.The foam pad should be used for the dynamic (foam) surface conditions in the CTSIB test.

CONTENTS


PeRFoRMING a CtSIB.To perform the CTSIB test, simply follow screen prompts.

1. Select the m-CTSIB from the test screen menu

2. Address each screen as you progress through the menus. The default test conditions are four m-CTSIB conditions.

Position Patient: Position the patient’s feet as noted. If patient cannot be positioned as suggested, center patient and enter new foot position. The foot angle is determined by the line that isparallel with the inside of the foot.

NOTE: Foot placement is based on height.

• < 53” defaults to a foot angle of 10/10 and Heel position of F7/F15 respectively.• 53-59” defaults to a foot angle of 10/10 and Heel position of E7/E15 respectively.• 59-65”and 65- 73” default to a foot angle of 10/10 and Heel position of D67/D16 respectively.• 73” + defaults to a foot angle of 10/10 and Heel position of C5/C17 respectively.

CONTENTS


Reference: McIlroy WE, Maki BE. Preferred placement of feet during quiet stance: development of a standardized foot placement for balance testing. Clinical Biomechanics Vol 17,No. 1 66-70 1997

3. If you do not want to follow the default test conditions, Select More Options. Here you can setthe Test Trial Time, enter the number of trials, adjust the Rest Countdown, and change whichconditions you want to test by simply touching to highlight the conditions you want to do.You can also toggle the cursor ON/OFF. The cursor should be OFF during the actual test.Touch <OK> to confirm your selections and return to the Testing screen.

• Use the <�> or <�> keys to set the Test Trial time in five-second increments (during the routine the system will count down from the time setting selected).


CONTENTS


Press <OK> to continue to do the test. The Press <START> to being the testing sequence foreach condition.

Again as with the other tests you will have the option to perform a trial rep prior to each testcondition rep. The practice rep can be stopped at anytime to proceed to the test rep.

After completing the condition the next test condition will follow until all conditions have beencompleted. When the last condition is completed a “Test Complete” message is displayed.Touch <Results> to advance to the CTSIB Test Results screen.

CONTENTS


4. At the Results screen, touch <Print> to automatically generate a printed report if desired.

1. To save the test data, touch <Save Results> and then touch <OK> in response to the“Save Results for later reporting or export?” prompt. The system will display “SaveResults Completed” after the results are saved.

2. Another test for the same patient can be performed. Press <Another Test Same Patient>.Pick desired test from the test selection menu.

3. To return to the Opening Menu from the CTSIB Test Results screen touch <Home>.

4. Note in the results, if a patient could not complete a stage, the stage is noted as “Fell”.

the CtSIB presents results in a manner that is easy to understand and communicate.

1. A description of the relationship of the test condition to the sensory system is provided whenthe m-CTSIB protocol format of 4 conditions is used. Space limitations preclude the descrip-tion for 6 conditions. The 4 condition m-CTSIB test is the preferred test protocol anyway.

2. The results are presented relative to the upper limit of the “normal” reference data. Patient results will either be better, equal to or worse than normal. The higher the Sway Index score – the more unstable the patient was for the condition. Total instability where they hadto hold onto something or stop is considered a Fall and is noted as Fell in the test results.

3. The number at the midpoint of the scale is the upper limit of the normal score, rounded tothe nearest .25 . For example.a. Eyes open firm high value is .48. The noted value is .50b. Eyes closed firm high value is .99. The noted value is 1.0c. Eyes open foam high value is .71. The noted value is .75d. Eyes closed foam high value is 2.22. The noted value is 2.25

The end point for the RED zone is three times the mid point. Basically three standard deviationsfrom the mid point.

See Balance Overview and the CTSIB report interpretation sections for more specific information.

CONTENTS


Biodex Balance System SD offers reports for each of the five test modes. These can be used toobjectively measure and record the patient’s ability to stabilize the involved joint under static ordynamic stress. Reports can be generated to reflect single leg, both legs and bilateral comparisontesting protocols. Report formats include Postural Stability, Limits of Stability, Athlete SingleLeg, CTSIB and Fall Risk. Progress reports that graph overall stability scores from each test dateare also available.

Sample reports for each testing mode are provided later in this chapter.

RePoRt PaRaMeteRS DeFINeD

The following parameters appear on various reports:

Stability Level: Indicates the stability (stiffness) of the foot platform. When "locked", the foot plat-form is fully stable. A setting of 12 is the most stable "released" setting. A setting of one is theleast stable foot platform setting. Stability settings of 12 through one allow the foot platform afull 20 degrees of deflection from level in any direction. For patient centering prior to testing,the foot platform deflection is limited to less than five degrees.

Overall Stability Index (SI): Represents the variance of foot platform displacement in degrees,from level, in all motions during a test. A high number is indicative of a lot of movement duringa test with static measures; it is the angular excursion of the patient's center of gravity.

Use as a starting point for a perfectly balanced state.COB x=0; COB y=0 COB is "Center of Balance"

Anterior/Posterior (AP) Stability Index: Represents the variance of foot platform displacement indegrees, from level, for motion in the sagittal plane.

9. REPORTS

— 9-1 — REPORTS

∑ (0 - X)2 + ∑ (0 - Y)2

number of samplesOverall Stability Index =

∑ (0 - Y)2

number of samplesAnterior/Posterior Stability Index =

= (

(Dl) =

Dly =

n

Xn2 + Yn

2 (p

Medial/Lateral (M/L) Stability Index: Represents the variance of foot platform displacement indegrees, from level, for motion in the frontal plane.

Mean Deflection: Average position for the patient in all motions throughout the test.

A/P Mean Deflection: Average position of side-to-side motion for the patient throughout the test.

M/L Mean Deflection: Average position for the patient in the frontal plane throughout the test.

Standard Deviation: The amount of variability in the statistical measure. A low standard devia-tion demonstrates that the range of values from which the mean was calculated were closetogether.

NOTE: Mean, A/P and M/L Deflections are from the patient’s actual position in contrast to the StabilityIndex, which is a variance from level as established during the centering patient portion of the test proto-col. The resulting scores for Mean, A/P and M/L Deflections are not statistically effected by the centeringprocess.

12. SYSTEM UTILITIES

REPORTS — 9-2 —

∑ (0 - X)2

number of samplesMedical/Lateral Stability Index =

= (

Dlx =

= (

∑ (Xn, Yn) Mean Deflection =n

n

n

∑ Yn

nA/P Mean Deflection = n

n = # of samples

Yn = n th sample

∑ Xn

nM/L Mean Deflection = n

n = # of samples

Xn = n th sample

Xn2 + Yn

2(Xn, Yn) = (position vector magnitude)

∑

∑ (Xn - X)2

nStandard Deviation = n

n = # of samples

Xn = n th sample

X = mean deflection

n

Percent Time In Zone/Quadrant: These values represent the percentage of test time the patientspends in each Zone/Quadrant during the test.

The Target Zones, A, B, C, and D, are equal to specific ranges of deflection and radiate in con-centric circles from the center of the foot platform as follows:

• Zone A = zero to five degrees foot platform deflection from level• Zone B = six to ten degrees foot platform deflection from level• Zone C = 11 - 15 degrees foot platform deflection from level• Zone D = 16 - 20 degrees foot platform deflection from level

Quadrants represent the four quarters of the Test Grid in the X and Y axis as follows:

For the "Both Feet" protocol:• Quadrant 1 = right anterior• Quadrant 2 = left anterior

Quadrants represent the four quarters of the Test Grid in the X and Y axis as follows:

For the "Both Feet" protocol:• Quadrant 3 = left posterior• Quadrant 4 = right posterior

For the "Single Foot" protocol:• Quadrant 1 = lateral anterior• Quadrant 2 = medial anterior• Quadrant 3 = medial posterior• Quadrant 4 = lateral posterior

Test Grid: Provides a visual representation of Time Spent in Zone/Quadrant. View is orientatedas if patient were looking down at foot platform while facing the display module.

Anterior/Posterior and Medial/Lateral Deflection Graphs: Provides a visual representation of A/Pand M/L deflection during the test. View is oriented as if foot platform were positioned at eyelevel on a horizontal plane. X axis = time and stability level.

CONTENTS

— 9-3 — REPORTS

SaMPle BalaNCe RePoRtS(See Figures 9-1 –9-8.)

9-1: Sample Postural Stability Single Leg Test Report.

CONTENTS

REPORTS — 9-4 —

9-2: Sample Postural Stability Bilateral Comparison Test Report.

13. BIODEX BALANCE SYSTEM REIMBURSEMENT

— 9-5 — REPORTS

9-3: Limits of Stability Single Leg Test Report (unilateral stance).

14. GENERAL MAINTENANCE

REPORTS — 9-6 —

9-4: Limits of Stability Test Report (bilateral stance).

15. SERVICE PROCEDURES

— 9-7 — REPORTS

9-5: Athlete Single Leg Stability Test Report

CONTENTS

REPORTS — 9-8 —

9-6: Fall Risk Test Report. Comparison to normative data can be made for population-specific tests usingthe Fall Screening and Athlete Single-Leg Stability protocols.

CONTENTS

— 9-9 — REPORTS

9-7: CTSIB Report. Utilizing the CTSIB capabilities clinicians can test patients and compare results tonormative data.

CONTENTS

REPORTS — 9-10 —

PRoGReSS RePoRtSProgress Reports graph overall stability scores for each test date selected. The tests are selectedfrom Patient Maintenance on the Utilities Menu. The patient selected must have multiple tests,with resultant Stability Index scores, for either Postural Stability, Fall Risk or Athletic Single Legtest formats.

Figure 9-8. A Postural Stability Progress Report.

to Print a Progress Report:

1. Touch <Utilities> on the Main Menu. The System Utilities screen should now be displayed.

2. Touch <Patient Management> and enter code 781 to advance to the Patient Managementscreen.

3. Touch the desired patient test and then touch <Progress Report>. Note that the report willbe limited to the specific test type selected.

4. Up to ten test records can be displayed on the screen. Scroll right or left to see additionaltests.

5. Touch <Print> to print the Progress Report.

CONTENTS

— 9-11 — REPORTS

Figure 9-9. Progress Report graphs overall sway index scores for each test date. Recall patients from thedatabase to repeat tests or rehab sessions. Prior foot position is displayed for standardization.

CONTENTS

REPORTS — 9-12 —

aSSeSSING lIMItS oF StaBIlItY WItH tHe BIoDeX BalaNCe SYSteM

The Limits of Stability (LOS) for standing balance has been defined as the maximum angle abody can achieve from vertical without losing one’s balance. Once the LOS is exceeded a fall,stumble or step will ensue. LOS in normal adults is eight degrees anterior, four degrees posteri-or, and 16 degrees in the lateral direction.

In the static mode the patient’s movements are calculated as the average amount of angular dis-placement of the Center of Gravity (COG). This is then further defined as a percentage of thepatients’s Limits of Stability.

At 100% of the LOS, a patient will fall if they don’t respond appropriately.

Center is established in the test protocol during the centering process where patients must posi-tion themselves so the platform is flat and the cursor is centered. In actuality, this process is toposition the COG over the point of the vertical ground reaction force.

An Anterior/Posterior Stability Index of 6.8 means the average displacement from center is 6.8degrees. LOS for A/P motion is 12 degrees. In this case, the patient was able to control their bal-ance to remain within 57% of their A/P LOS.

Balance is a complex process involving visual, vestibular and neuromuscular control. TheBiodex Balance System will prove to be a more sensitive test of balance performance becausebeing a dynamic tilting platform it will invoke the neuromuscular control aspects more so thana static force plate type system, as well as the visual and vestibular components.

The Biodex Balance System will provide an accurate, reliable assessment of a patient’s balanceperformance. This objective measure can be correlated to actual functional activity performance,fall incidence and fall direction. In addition, balance mobility programs can be evaluatedthrough objective assessment of the effects of lower extremity exercise on balance performance.

INteRPRetING PatIeNt PeRFoRMaNCe

The patient’s performance is noted in the following ways:

1. Stability Index:The stability index represents the variance of platform displacement in degrees from level. Ahigh number is indicative of a lot of motion which is indicative of the patients having troublebalancing. Differences between right and left limbs can be noted.

2. Percent Time in Zone Quadrant:Example: If a patient with a right lateral ankle sprain spends the vast majority of time in Zone 1,the trend will be to fall into inversion. This gives feedback as to the exact ankle position beingchallenged.

3. Test Grid:For testing, as the patient goes further and further from the center of axis, the patient is beingchallenged to sustain proper position. For rehabilitation, we can note how far the patient candeviate from the center and still maintain a proper position.

10. DATA

— 10-1 — DATA

BalaNCe SYSteM StatIStIC DeFINItIoNS

Stability Index: Represents the variance of platform displacement in degrees from level. A high

number is indicative of the patient having trouble balancing. The patient's Actual Stability Index

is represented in the Postural Stability, Athletic Single Leg and Fall Risk Report under the col-

umn labeled "Actual Score." The Actual Score can be compared to age related Predictive Score,

this is found to the immediate left of the Actual Score under the column labeled "Predictive

Values." Should your patient's Actual Values not fit into the range of the Predictive Values there

maybe a balance problem. Bilateral comparisons can be made to determine progress made dur-

ing rehabilitation on the Comparative Report (see Figure 9-2).

Anterior/Posterior Stability Index: Represents the variance of platform displacement in degrees

from level for motion in the sagittal plane.

Medial/Lateral Stability Index: Represents the variance of platform displacement in degrees from

level for motion in the frontal plane.

Standard Deviation: The amount of variability in the statistical measure. A low standard devia-

tion demonstrates that the range of values from which the mean was calculated were close

together.

CONTENTS

DATA — 10-2 —

System Utilities allow users to access the System Configuration and Patient Management screens.

To access the System Utilities, touch <Utilities> on the Main Menu. The System Utilities screenshould now be displayed. From here you can select Configuration or Patient Management bytouching the desired icon.

SYSteM utIlItIeS includes • CONFIGURATION• PATIENT MANAGEMENT• CUSTOM PROTOCOL LIST• PATIENT DATA STORAGE USAGE• PLATFORM SET-UP• SOFTWARE AND HARDWARE INFORMATION• HOURS OF USE

Patient Data Storage usage MeterPatient Data Storage Usage is scaled to 6,000 patient tests. When storage reaches 85% of itscapacity, it is suggested that patient tests be deleted or archived. You may archive patient datato a USB memory device or to a computer or network using the Biodex Patient Data CollectionSoftware.

11. SYSTEM UTILITIES

— 11-1 — SYSTEM UTILITIES

CoNFIGuRatIoN(See Figure 11.1.)

At the System Utilities screen, touch <Configuration> and then enter 781 in response to the"Enter Access Code" prompt. Touch <OK>. The Configuration screen should now be displayed.At this screen users can set values for Screen Time Out, Screen Saver, Date/Time, Fall RiskDefaults, m-CTSIB Defaults and Change Access ID Code. You can also turn Tone ON/OFF,adjust LCD brightness or Tone volume, and select Measurement Units, Printer Resolution orJoystick Emulation. When you have finished making all of your selections and adjustments,touch <OK> to return to the Main Menu.

Figure 11.1. The Configuration screen.

Set SCReeN tIMe out

The Screen Time Out setting determines how long the display screen remains ON when the system is no longer in use following a test/exercise. Once the selected time expires, the systemreturns to the Main Menu.

1. At the Configuration Screen, touch <Set Screen Time Out>. The Set Test/Exercise CompleteScreen Time Out screen should now be displayed.

2. Use the < ▲> or < ▼> arrows to increase or decrease the value displayed in 00:30 secondincrements. The Time Out range is from 00:00 to 30:00.

3. Touch <OK> to confirm your changes and return to the Configuration screen. Touch<Cancel> to return to the Configuration screen without making any changes.

CONTENTS

SYSTEM UTILITIES — 11-2 —

SCReeN SaVeR

The Screen Saver setting determines how long the display screen remains ON when the system is no longer in use. Once the selected time expires, the screen fades to black even if thesystem remains ON.

1. At the Configuration Screen, touch <Screen Saver>.

2. Use the < ▲> or < ▼> arrows to increase or decrease the value displayed in 1 minute increments. The Time Out range is from 00:00 to 60:00.


Set Date/tIMe

Time and Date are system-wide parameters that show on all printed reports.

1. At the Configuration Screen, touch <Set Date/Time>. The Set System Date/Time screenshould now be displayed.

2. Touch the parameter to set so that the selected field is highlighted.

3. Use the <�> or <�> arrows to increase or decrease the value displayed for the highlightedparameter.

4. Repeat steps 2 and 3 until you have adjusted all the parameters you wish to correct.


Fall RISK DeFaultS(See Figure 11.2.)

At the Fall Risk Default Settings screen, users can set the default Fall Risk Platform settings,adjust Predictive Values, or return these parameters to their original factory-set default values.

Figure 11.2. System Fall Risk Defaults Settings

CONTENTS


to adjust Fall Risk Platform Setting:1. At the Configuration Screen, touch <Fall Risk Defaults>. The Fall Risk Defaults screen

will appear.

2. Touch the Fall Risk Platform Setting you would like to adjust (Initial or Ending). An adjustment selection screen will appear.

3. Enter the desired platform setting via the key pad displayed.

4. Touch <OK> to return to the Fall Risk Defaults screen.

to adjust Predictive Values:1. At the Configuration Screen, touch < Fall Risk Defaults>. The Fall Risk Defaults screen

will now be displayed.

2. Touch to highlight the predictive value you wish to adjust.

3. Use the < ▲> or < ▼> arrows to increase or decrease the value displayed

M-CtSIB DeFault SettINGS(See Figure 11.3.)

At the m-CTSIB Default Settings screen, users can set which conditions of the CTSIB they wantas defaults for testing as well as the ability to enter in or change the Sway Index Goals. Defaultsettings can be restored to “factory” defaults by touching <Restore Defaults>.

Figure 11.3. System m-CTSIB Defaults Settings.

16. TROUBLE-SHOOTING


to adjust the CtSIB age Range:1. At the Configuration Screen, touch < m-CTSIB Defaults>. The m-CTSIB Defaults screen will

now be displayed.

2. Select <Age Range>.

3. Select the Age Range you would like to adjust. The From and To values in the range willappear on the screen.

4. Select the value you would like to adjust. Adjust the value using the < ▲> or < ▼> arrows orthe key pad displayed.

5. Press <OK> to save the adjustment(s) and return to the m-CTSIB Age Range screen.

6. Press <OK> from the m-CTSIB Age Range screen to return to the m-CTSIB Defaults screen.

to add an age Range1. At the Configuration Screen, touch < m-CTSIB Defaults>. The m-CTSIB Defaults screen will

now be displayed.

2. Select <Age Range>.

3. Select the <Add> Age Range button at the bottom of the screen.

4. A new Age Range screen will appear. The From and To values in the range will also appearon the screen.

5. Select the value you would like to set. Adjust the value using the < ▲> or < ▼> arrows orthe key pad displayed.

6. Press <OK> to save the new age range and return to the m-CTSIB Age Range screen.

7. Press <OK> from the m-CTSIB Age Range screen to return to the m-CTSIB Defaults screen.

CHaNGe aCCeSS ID CoDe

At the Default Settings screen, users can change the Access Code used to access the DefaultSettings screen.

to Change the access ID Code1. At the Configuration Screen, touch <Change Access ID Code>.

2. Select your New Access ID Code by entering the value using the < ▲> or < ▼> arrows or thekey pad displayed.

3. Press <OK> to save the New Access ID Code and return to the Default Settings screen.

17. BIBLIOGRAPHY


turn tone oN/oFFThis setting enables or disables an audible tone which signals test or exercise start, completionand countdown between trials.

1. At the Configuration screen, simply touch the ON or OFF icon to select the desired setting.

adjust lCD BrightnessThis setting brightens or darkens the display screen for all applications.

1. At the Configuration screen, simply touch along the LCD Brightness Bar Scale until the desired display brightness is achieved. The left end of the scale is darkest, the right end of the scale is lightest.

adjust tone VolumeThis setting raises or lowers the volume of the audible tone which signals test or exercise start,completion and countdown between trials.

1. At the Configuration screen, simply touch along the Tone Volume Bar Scale until the desiredlevel is achieved. The left end of the scale is least loud, the right end of the scale is most loud.

Select Measure units, Printer Resolution or joystick emulationAll three of these setting are simple toggle choices. Simply touch the desired parameter to viewthe choices, then touch the setting you want to select.

• Measurer Units: Metric or US• Printer Resolution: normal or high• Joystick Emulation: disabled or enabled

CONTENTS


PatIeNt MaNaGeMeNt(See Figure 11.4 - 11.6.)

At the System Utilities screen, touch <Patient Management > and then enter 781 in response to the"Enter Access Code" prompt. Touch <OK>. The Patient Management screen should now be dis-played. This screen shows a listing of patients and associated saved test and training sessions alongwith the date performed. Use the <�> or <�> arrows to scroll through the list of patient tests.

Figure 11.4. The Patient Management Screen.

View test Results(See Figure 11.4.)

To view the results of any test displayed simply touch the desired entry on the PatientManagement screen to produce an on-screen report.

Figure 11.6. A single, stored, patient Postural Stability Test Record.

CONTENTS


Repeat (recall a patient for a test or exercise session)To repeat any saved test or exercise session, touch <Repeat> on the on-screen report. The sys-tem will return to the appropriate test or training Position Patient screen with the position val-ues for foot and heel reflecting the selected session. The selected name, age and height of theselected patient will also be recorded with the new test or training session if you save at comple-tion.

Print test ResultsTo print test results for any patient, touch the desired test to generate an on-screen report thentouch <Print> to print the test results.

Single Patient exportTo export the results of any saved test, touch <Export Data>. The data will immediately sent tothe export program.

Single Patient Delete Although the Balance System SD display can store a significant number of test records, you maywant to decrease the number of stored records from time to time. To delete any full page displayof saved reports, touch <Delete>. Respond <OK> to the delete prompt. The page displayed will bedeleted from the display memory. The delete function only works with pages, you cannot select aspecific test or patient to delete without deleting every test and patient displayed on the screen.

Multiple Patient export (See Figure 11.6.)

NOTE: Store patient records on a USB memory device. Manage, view and print reports with PatientData Collection Software (Biodex part #950-389).

In addition to exporting any single patient record, multiple patient records can be exported.

1. At the Patient Management screen touch <Multiple Export> to export multiple patientrecords. The Multiple Patient Data Export screen should now be displayed.

2. Four options are available for multiple export: all (export all patient records); prior-to(export all patient records prior to selected date); from (delete all patient records after aselected date); and from-to (export all records between selected dates.) Touch <Options>until the desired option is displayed.

• For prior-to and from-to, touch the date displayed to advance to the date screen. Touchthe date section to change and use the <�> or <�> arrows to adjust.

3. Touch <Export Now> to export the selected patient files.

CONTENTS


Figure 11.6. For multiple export or multiple deletion of patient records, touch <Option> to select records based before or after a selected date, or between two selected dates.

Multiple Patient DeleteIn addition to deleting any single patient record, multiple patient records can be deleted.

1. At the Patient Management screen touch <Multiple Delete> to delete multiple patientrecords. The Multiple Patient Data Delete screen should now be displayed.

2. Three options are available for multiple delete: all (delete all patient records); prior-to(delete all patient records prior to selected date); and from-to (delete all records betweenselected dates.) Touch <Options> until the desired option is displayed.

• For prior-to and from-to, touch the date displayed to advance to the date screen. Touch the date section to change and use the <�> or <�> arrows to adjust.

3. Touch <Delete Now> to delete the selected patient files.

CONTENTS


Biodex Rehabilitation Equipment is commonly used in rehabilitation services based on a physician referral for these ICD-9 codes. As a result, these CPT codes may be applied.Reimbursement amounts vary among plans and states.

Physician referral and ICD-9 codes:

V15.88 Personal History of Fall728.87 Muscle weakness729.89 Leg weakness715.0 Degenerative joint disease715.2 Secondary localized osteoarthritis781.2 Abnormal gait719.7 Difficulty in walking719.4 Joint pain719.5 Joint stiffness718.8 Instability of joint780.40 Dizziness781.20 Imbalance850.00 Concussion without LOC850.10 Concussion with brief LOC850.11 Concussion with LOC<30 minutes850.12 Concussion LOC 31 to 59 minutes850.50 Concussion with unspecified duration of LOC850.90 Concussion unspecified (NOS)310.20 Post-concussion Syndrome (PCS)

the following CPt codes can be applied. Reimbursement amounts vary among plans and states.

97110 Therapeutic procedure, one or more areas, each 15 minutes;therapeutic exercise to develop strength, endurance, range of motion and flexibility.

97112 Neuromuscular reeducation of movement, balance, coordination, kinesthetic sense, posture, and/or proprioception for sitting and/or standing activities.

97116 Gait Training (includes stair climbing)97530 Therapeutic activities, direct (one-on-one) patient contact by the provider

(use of dynamic activities to improve functional performance), each 15 minutes97535 Self-care/home management t raining (eg, activities of daily living (ADL) and

compensatory training, meal preparation, safety procedures, and instructions in use of assistive technology devices/adaptive equipment) direct one-on-one contact by provider, each 15 minutes

97750 Physical performance test or measurement (eg, musculoskeletal, functional capacity) with written report, each 15 minutes

96992 Canalith Repositioning—specific maneuvers for BPPV

NOTE: Most insurance plans, including Medicare, cover assessment and conditioning for Fall Programs.

12. REIMBURSEMENT

— 12-1 — SYSTEM REIMBURSEMENT

The Biodex Balance System requires only the most basic general maintenance, performed on an

as-needed basis at least every three to four months.

CleaNING INStRuCtIoNSWith the system turned OFF, wipe down all surfaces with a damp cloth. Mild soap and water

can be used to remove stains and scuff marks. As needed, inspect all locking and adjustment

mechanisms for signs of wear or damage.

If you have any questions or need further assistance, contact the Biodex Customer Service

Department.

GeNeRal MaINteNaNCe PRoCeDuReS• Lubricate the spring assemblies with white lithium grease.• Lubricate the eight push plates with white lithium grease.• Lubricate the acme threaded rods with white lithium grease.

NOTE: When checking for lubrication, it may only be necessary to re-distribute the existing grease.

CAUTION! Some steps of these procedure require the Balance System to be turned ON. Whenthis is the case, use extreme caution working on the system.

ATTENTION: Certaines étapes de la présente marche à suivre nécessitent que le système d’équili-brage soit mis SOUS TENSION. En pareille circonstance, user de précautions extrêmes dans lamaniplation du système.

13. GENERAL MAINTENANCE

— 13-1 — GENERAL MAINTENANCE

CalCulatIoN oF lIMItS oF StaBIlItY DIReCtIoN CoNtRol

DIReCtIoN CoNtRol SCoRe % = X 100

WHeRe:

— A-1 — APPENDIX A

APPENDIX A

Actual

Distance

Traveled

(trace)

Straight Line Distance to Target

Actual Distance Traveled

Straight Line Distance to

Target

OVERALL DIRECTION CONTROL SCORE =

or the Average of all the eight Targets

(DLOS Scores)

8

i =8

i =1

CENTER

TARGET

BalaNCe SYSteM ClINICal teSt oF SeNSoRY INteGRatIoN aND BalaNCe (CtSIB) SWaY INDeX eQuatIoN

test DescriptionThe objective of this test is to quantitatively determine a score defining a patient’s ability tomaintain a stable vertical posture while positioned on a stationary platform. The patient is posi-tioned on a stable platform and instructed to try to maintain a stable vertical posture under avariety of sensatory conditions, eyes open, eyes closed, and vision partially obscured.

equipment DescriptionSway information is collected by positioning the patient on a static force plate and then sam-pling and recording patient movement. The system employs a series of strain gauges to deter-mine variation in the subject’s resultant center of pressure (COP). The center of pressure is thepatient’s center of gravity projection on the platform resulting from sway angle and the patientheight. Data is sampled at the rate of 20Hz. Each recorded sample consists of a (X, Y) coordi-nate. What is displayed is the sway angle derived from the position of the COG from zero andthe height of the patients COG taken as .55 times the patient height.

This data is recorded for later analysis and also displayed, in real time on, an LCD displayobservable by the patient. The resultant movement results in a “spaghetti plot” as shown below.This plot indicates patient movement from one sample to the next.

Essentially, the database consists of an array of (X, Y) coordinates defining the calculated COP.The data can be interpreted as an ordered series of sequential vectors from point to point.

For example: (X0, Y0)(X1, Y1)(X2, Y2)……….……….(Xn, Yn)

CONTENTS

APPENDIX A — A-2 —

The “Score” is defined as the standard deviation of position over the length of the test. TheStandard deviation is interpreted to be the absolute vector length deviation from the mean vec-tor end point. Basically, all vectors (X,Y) coordinates are summed and divided by the number ofsamples, to obtain a vector sum which represents the position of the mean.

andN-1 2 2

φ = sqrt(Σ((Xn-sx)+(Yn-sy) )n = 0

N

CONTENTS

— A-3 — APPENDIX A

Xn

N=1

N=0

sx

Yn

N=1

N=0

sy

NoRMatIVe Data ReFeReNCeD IN PReDICtIVe ValueS RePoRt

Joan A. Finn, D.P.E., Exercise Science Department, Southern Connecticut State University, New

Haven, CT - May 2010

testing Protocol:The testing protocol consisted of three 20 second trials using the postural stability testing feature

within the BSD software. During each test trial, the platform gradually became less stable at

four second intervals. The initial stability level was set at level 12 and ended at level 8.

Participants were given a 10 second rest between each of the three trials.

Data analysis:Statistical tests were carried out using the Statistical Package for the Social Sciences (SPSS, Inc.,

Chicago, IL). Data were analyzed using ANOVAs with age and balance ability as the independ-

ent variables. The Bonferroni post-hoc test was applied as necessary. The confidence level was

set at 0.05.

ReSultS

Table 1 and Table 2 include descriptive statistics for age and balance independent variables.

Statistical analyses identified significant differences in balance scores for both independent vari-

ables. These differences are included in the text presented after each Table.

table 1: Stability Index Differences among age Groups

Youngest Sec youngest third oldest oldest

Group 1 Group 2 Group 3 Group 4

Age 18-35 36-53 54-71 72+

Sample Size N = 50 N = 52 N = 50 N = 17

OSI Average 1.4 1.9 2.3 3.0

OSI SD 0.7 1.2 1.4 1.0

There was a significant mean difference for balance scores between:

1. Age group 1 and Age group 3

2. Age group 1 and Age group 4 and

3. Age group 2 and Age group 4

That is, the youngest subjects were more stable than the third oldest subjects. The youngest

subjects were more stable than the oldest subjects. And the second youngest subjects were more

stable than the oldest subjects.

Also, the two youngest groups were similar in their balance stability and the two older groups

were similar in their balance stability.

— B-1 — APPENDIX B

APPENDIX B

CtSIB NoRMatIVe Data ColleCtIoN aND RelIaBIlItY

CTSIB reliability and predictive score data were collected from 100 randomly recruited people.All test subjects were healthy, active, working people. Medical history was recorded via a confi-dential questionnaire. The testing and protocol followed IRB approval and was performed onsite.

In addition to the CTSIB, all 100 recruits participated in a Timed Get up and Go (TUG) and GaitSpeed assessment. The TUG and Gait Speed tests are accepted tests for Balance assessment. Thereason for doing the additional tests with the CTSIB was to strengthen the results when a posi-tive correlation is made between the three accepted standardized assessments. Subjects weretested initially then again 2 weeks later. A third follow test was administered 3 months later on27 of the original 100 subjects. This third test was to negate any learning effect in the initial test-retest (given they were done consecutively with less than 2 weeks between trials).

Descriptive Statistics

N Minimum Maximum Mean Std. Deviationage 100 17.00 72.00 45.4400 10.80621

gender 0

Height (meters) 101 1.45 2.00 1.7263 .11410

Weight (KG) 101 44.09 137.73 81.4784 19.06182

Waist (CM) 59 26.00 44.00 34.4576 4.01000

bmi 101 12.50 44.60 27.3748 5.50826

Valid N (listwise) 0

Reliability: The resultant ICC is .81, which is considered acceptable.

Intraclass Correlation CoefficientIntraclass Correlation 95% Confidence Interval F Test with True Value 0 Lower Bound Upper Bound Value df1 df2 Sig Lower BoundSingle Measures .668 .573 .745 5.024 161.0 161 .000Average Measures .801 .729 .854 5.024 161.0 161 .000Two-way mixed effects model where people effects are random and measures effects are fixed.a Type C intraclass correlation coefficients using a consistency definition-the between-measure variance is excludedfrom the denominator variance.b The estimator is the same, whether the interaction effect is present or not.c This estimate is computed assuming the interaction effect is absent, because it is not estimable otherwise.

CTSIB Normative Sway Index ranges are:Condition 1: Eyes Open firm surface: .21-.48Condition 2: Eyes closed firm surface: .48-.99Condition 3: Visual conflict firm surface: .46-.88Condition 4: Eyes Open foam surface: .38-.71Condition 5: Eyes Closed foam surface: 1.07-2.22Condition 6: Visual conflict foam surface: .84-1.47

APPENDIX C

— C-1 — APPENDIX C

BalaNCe oVeRVIeW

Maintaining postural balance involves complex coordination and integration of multiple sensory,motor, and biomechanical components as graphically represented below. Balance is a motor skillmost people take for granted. An individual senses body position in relation to gravity and envi-ronmental surroundings by combining vestibular, visual, and proprioceptive (somatosensory)inputs (1). Body position and smooth functional movement patterns result from these coordinatedactions along with integration of graded ankle, knee and hip movements along the kinetic chain (2).

A person’s ability to maintain Balance becomes compromised when one action does not func-tion accordingly and or equilibrium becomes altered. A variety of consequences can occur dueto poor balance therefore clinicians need to address each component in order to prevent injury,re-injury or further trauma. The Biodex BioSway provides valuable objective assessment of neu-romuscular control and somatosensory input important to balance.

MoVeMeNt StRateGIeS FoR BalaNCe, SeNSoRY oRGaNIZatIoN, aGe-RelateDCHaNGeS IN BalaNCe aND CtSIB teSt ReSult INteRPRetatIoN.

MoVeMeNt StRateGIeS FoR BalaNCe (Robertson)

According to the Systems Approach to motor control, the nervous system uses preprogrammedstrategies or synergies to simplify movement. The central nervous system (CNS) takes advan-tage of pathways that link together groups of muscles in a flexible and repeatable sequence. Thislinking or packaging of muscle groups allows the brain to respond to an infinite variety of cir-cumstances by drawing on muscle responses that have been successful in the past. This linkingor packaging of muscles in a repeatable sequence is called a movement strategy.

Utilizing a movement strategy simplifies the way the nervous system accesses a motor reactionin response to sensory input. Strategies are automatic reactions that have evolved over time, tak-ing into account biomechanical and environmental constraints. Strategies that are successful formaintaining balance are stored so that the CNS is not forced to start from scratch each time aloss of balance occurs. Strategies are automatic reactions, slower than reflexes but much fasterthan voluntary movements. Three anterior-posterior movement strategies have been identified:the ankle, hip and stepping strategies.

ankle StrategyThe nervous system employs the ankle strategy in response to small losses of balance and toadjust balance in quiet standing. The ankle strategy is also called ankle sway and uses the lengthof the foot as a lever to correct for minor losses of balance. In the ankle strategy, activation of theleg muscles is from the floor up or distal to proximal. A small loss of balance in the forwarddirection causes contraction of the gastrocnemius, hamstrings, and lower-back muscles, in thatorder, to bring the body back into balance.

APPENDIX D

— D-1 — APPENDIX D

Figure C.1 Figure C.2

Figures D.1 and D.2: The ankle strategy that is used in response to small perturbations is also calledankle sway. Illustration © Wild Iris Medical Education.

A small loss of balance in the backward direction causes contraction of the anterior tibialis, quadri-ceps, and lower abdominal muscles, in that order, to bring the body back into balance. Our bodiesare constantly using this strategy to adjust for minor losses of balance. For example, you woulduse the ankle strategy to maintain balance when standing on a bus, to correct for losses of balanceand to prevent yourself from falling as the bus changes speed. You might also use the ankle strate-gy to maintain your balance on a very soft surface such as thick grass or a piece of foam.

Hip StrategyThe hip strategy describes movement about the hip in response to larger losses of balance orwhen the support surface does not allow the use of the ankle lever, such as on an icy surface orwhen the surface is shorter than the length of the foot. In the hip strategy, activation of musclesis from the trunk down, or proximal to distal. A loss of balance in the forward direction causescontraction of the lower-back and hamstring muscles, in that order, to regain balance.

When the hip strategy is used, the muscles of the lower leg (anterior tibialis and gastrocnemius)are almost silent. Studies have shown that when a walker is used, the body largely abandons theankle strategy and relies heavily on the hip strategy for balance. This dependence on the hipstrategy for balance paradoxically may lead to a decrease in ankle sway and contribute to fur-ther decline in balance arising from loss of ankle strength and flexibility. For this reason the prosand cons of walker use must be carefully considered before a walker is recommended for fulltime use.

Stepping StrategyThe third strategy employed by the nervous system for balance is the stepping strategy. Thisstrategy is used when the loss of balance exceeds the area of stability and the person is forced tostep or fall.

CONTENTS

APPENDIX D — D-2 —

SeNSoRY oRGaNIZatIoN FoR BalaNCe

Perhaps the most confusing part of a balance evaluation is the part that examines the sensory sys-tem and its contribution to balance. The sensory system includes the eyes, ears, vestibular appara-tus (inner ear), somatosensory system (touch and proprioception), taste, and smell. The parts ofthe sensory system that contribute directly to balance are the visual, vestibular, and somatosenso-ry (touch and proprioception) systems. The use of multiple systems in balance allows us to learnnew movements quickly and to fine-tune and easily repeat familiar movements.

The sensory system receives input from the environment through specialized receptors locatedin the sensory end-organs in the eyes, vestibular apparatus of the inner ear, muscle spindles,Golgi tendon organs, and touch receptors in the skin. Sensory input is transmitted to the spinalcord via afferent nerve fibers and then to the brain via spinal nerve tracts such as the spinothala-mic tract (pain and temperature) and the dorsal column medial lemniscal tract (fine touch, mus-cle and tendon position sense).

Sensory input provides a continuous flow of information to the CNS, which in turn utilizes thisincoming information to make decisions about movement. The CNS sifts, compares, weighs,stores, and processes sensory input and uses this information to alter the force, speed, and rangeof a movement.

VisionVision is a critical part of our balance system. It allows us to identify objects and determine theirmovement and tells us where we are in relation to other objects (object-to-object orientation).When we use vision to gather information about the position of our body in the environment orto determine the position of one body part vis à vis another, then vision is providing proprio-ceptive information to the CNS as well (visual proprioception).

Vision works in conjunction with the vestibular system, comparing information about velocityand rotation from the vestibular system with actual visual information. The visual system is acombination of both central and peripheral vision, although some research has suggested thatperipheral vision is more important for postural control and balance than central vision(Shumway-Cook & Woollacott, 2001).

The visual system may provide inaccurate information to the nervous system. For example, aperson sitting at a stoplight in a car may think she has started to move when the car next to herstarts to move. The visual system “goes along” with the movement of the neighboring car andtells the brain that both cars are moving. The CNS mediates this sensory conflict by instructingthe leg to slam on the brake to stop the car from moving forward. As soon as the foot touchesthe brake the somatosensory and vestibular systems realize that the car is, in fact, not moving.For a split second, input from the visual system was given preference by the brain, even thoughthe information turned out to be inaccurate.

Visual input may also be inaccurate due to diseases or disorders that affect the visual system,such as diabetic retinopathy, cataracts, macular degeneration, injuries, or stroke.

Vestibular InputThe vestibular system is responsible for processing information about movement with respect togravity —specifically, rotation, acceleration/deceleration, and head stabilization during gait.The vestibular system works in conjunction with the visual system to stabilize the eyes andmaintain posture during walking (vestibular-ocular reflex). Vestibular disorders cause a feelingof dizziness and unsteadiness. Vestibular dysfunction also affects the ability of the CNS to medi-ate intersensory conflicts such as that in the example given above.

CONTENTS


Somatosensory InputSomatosensory input consists of touch and proprioception. Input from these two sensorysources provides critical feedback to the CNS regarding positioning in space, body sway, andchanges in terrain. The sensory input from touch and proprioception allows the muscles tomake constant, automatic adjustments to maintain balance and avoid falls.

In the example where the person in the stationary car slams on the brake, only to realizethrough somatosensory input that her car has not moved, the feeling that the car is movingwhen it is not is an example of a visual intersensory conflict; the conflict is resolved quickly bypressing on the brake and feeling that the car has not moved.

Sensory DisorganizationThe loss or disruption of sensory input in the visual, vestibular, and/or somatosensory systemscan affect balance in a number of ways. How balance is affected depends on several factors,including the extent of the nervous system damage, the number and extent of sensory losses,and the availability of the other senses for compensation. In many instances, more than one sen-sory system is impaired, as in the case of a person with a peripheral neuropathy and visualimpairment (common with diabetes and stroke). But, just as an individual with impaired visiondevelops a keener sense of hearing, a person with any sensory loss will attempt to compensateby using the unaffected or less-affected senses to improve balance.

Sensory lossThe way balance is affected by loss of sensory input depends on the extent and nature of thesensory loss. Recall that the senses most associated with balance are somatosensory (touch andproprioception), visual, and vestibular. Of these, the somatosensory system plays the biggestrole in balance, so losses associated with peripheral neuropathies, stroke, and other neurologicdisorders can have a profound effect on balance.A person with sensory loss (eg, bilateral lower-leg peripheral neuropathy) who does not receivenormal sensory input from the sensory receptors in the feet and ankles will attempt to compen-sate by depending more on visual and vestibular input for balance. If there is significant sensoryloss in the feet, a person will be unable to adjust easily to changes in the support surface duringtasks such as walking on grass or uneven surfaces, or even walking in shoes with soft soles.

A person with impaired vision from a stroke or cataracts will depend less on vision and moreon touch and vestibular feedback for balance. In this case, choice of assistive device, hand rail-ings for touch, and proper lighting are important. A person with a visual impairment may per-form well in a clinical setting but have difficulty with balance in more complex visual situationsthat demand rapid visual interpretation of multiple visual cues. For example, a person may besafe walking in a quiet, well-lit hallway but be unable to negotiate a busy, noisy hallway filledwith people and equipment.

Vestibular damage or loss can also have a profound effect on balance and postural control.Vestibular impairment can cause problems with gaze stabilization, including blurred vision,problems with balance and posture, and vertigo (Shumway-Cook & Woollacott, 2001).

Improper Sensory SelectionSensory loss may lead to inflexible or improper sensory weighting. A person may depend onone particular sense for postural control even if that sense leads to further instability(Shumway-Cook & Woollacott, 2001). You may notice a person walking with head down, care-fully watching every step. In this case, vision is the dominant sense being used for balance.Retraining would involve improving the use of somatosensory and vestibular input to reducedependence on visual input.

CONTENTS


abnormal Internal RepresentationsIndividuals’ perceptions of their limits of stability are difficult to assess and understand. Illnessand injury, including stroke, clearly affect confidence and may alter perceived stability limits. Aperson’s stability may be affected by fear of falling, even when the physical ability exists to per-form a task safely. Conversely, individuals may not have an accurate idea of the limits of theirstability and thus have little warning when loss of stability is occurring, leading to falls.

Sensorimotor adaptationThe nervous system has a powerful ability to compensate for actual or perceived disabilities.Once an injury has occurred, the nervous system immediately goes to work attempting to com-pensate for neurologic changes, weakness, and loss of function. But the brain doesn’t alwayschoose the best (or even a good) compensation; it chooses the fastest and most efficient in anattempt to continue functioning. One of the immediate goals of therapy is to help the nervoussystem develop strategies and compensations that minimize musculoskeletal damage and maxi-mize function.

aGe-RelateD CHaNGeS IN BalaNCe

Many changes in balance relate to normal aging. Some changes (i.e., slowed gait, decrease inlower-extremity strength, decreased ROM) can be easily addressed with a daily exercise pro-gram. Other changes (i.e., declining visual ability, including loss of visual acuity, declining visu-al fields, light-dark adaptation, increased sensitivity to glare, loss of peripheral vision and depthperception) are more complex and may require assessment by another healthcare professionalsuch as an optometrist or ophthalmologist.

Age-related changes in balance are the result of changes in every system in our bodies.Neurologic changes include slowed response to losses of balance, decreased righting responses,and abnormal sensory selection or weighting (i.e., overuse of vision or underuse of propriocep-tion). Orthopedic changes include loss of ankle sway, leading to an increase in the use of the hipand stepping strategies and lower-foot swing height. Psychomotor changes include loss of confi-dence (changes in the perceived limits of stability) and a propensity to fall in new or novel situa-tions, perhaps due to impaired anticipatory mechanisms. Sensory changes include abnormalsensation (i.e., peripheral neuropathies, abnormal tone, effects of drugs, visual disturbance suchas hemianopsia) and a reduction in the function of the vestibular system of the inner ear(Shumway-Cook and Woollacott, 2001).

CONTENTS


CtSIB teSt ReSult INteRPRetatIoN (Neurocom)

The CTSIB is the Clinical Test for Sensory Integration and Balance. The CTSIB is the standardtest for differentiating balance problems as a result of visual, vestibular or somatosensory

The CTSIB uses 4 conditions to test contribution of visual, vestibular and somatosensory inputs:

1. Eyes Open, firm surface: This is the baseline condition. Accurate information is available to allthree sensory systems: visual, vestibular and somatosensory. Normal individuals are very stable inthis condition.

2. Eyes Closed, Firm surface: No visual input is available. The Patient must rely on somatosen-sory and vestibular inputs. Somatosensory is the primary sensory input. Vestibular inputs aresecondary. High sway scores are indicative of problems with somatosensory. In normal indi-viduals there is no significant difference in sway with eyes open or closed on a firm surface.

3. Eyes Open, Unstable (foam) surface. The unstable surface confounds the somatosensoryinformation as it imposes additional challenges to the musculoskeletal system. Primary inputsare visual with vestibular as secondary. Normal individuals will sway more on the unstable sur-face, but will not fall.

4. Eyes Closed, Unstable (foam) surface: This condition focuses on the vestibular sensory input asvisual is not available and somatosensory is challenged by the unstable surface. Again nor-mal individuals will sway more on the unstable surface, but will not fall.

To interpret or apply the test results consider under what condition was sway the greatest?

Normal balance includes the ability to hold still in various situations depending on the activityor circumstance demands. The COG sway scores indicate how well the patient accomplishedthis. Lower scores reflect little movement which are consider better than higher scores whichreflect more movement.

Firm Surface: eyes open vs. eyes ClosedNormal individuals standing on a firm surface have similar amounts of sway with eyes open orclosed. On a firm surface, when significantly more sway is present with eyes closed then thepatient maybe having difficulty using somatosensory inputs (this is the input up from the feet).An ankle strategy should be used for primary balance control on a firm surface.

unstable (Foam) Surface: eyes open vs eyes ClosedWith Eyes open on an unstable surface, normal individuals have significantly more sway thenwhen standing on a firm surface. And even more sway on the unstable surface with their eyesclosed. However – they do not become overly unstable or fall. Patients that do become unstableor fall when standing on foam with eyes open may have difficultly using visual information forbalance control and/or may have lower extremity musculoskeletal problems. A hip strategyshould be used on unstable surfaces.

NOTE: These tests are targeting sensory integration deficits. Standing on an unstable surface presentsbiomechanical and musculoskeletal challenges. Patient with ankle or foot problems, joint weakness or painwill have high scores. As such in these patients it can not be assumed that sensory abnormalities are theunderlying cause, as they can not be distinguished from motor (musculoskeletal) issues. Ideally patientshould be screen for motor problems prior to the CTSIB test. Only patients without motor problemsshould be tested with the CTSIB. The LOS test is an effective test to tease out this question.

CONTENTS


eleCtRoMaGNetIC CoMPatIBIlItYThis equipment conforms to the following safety standards:

Table 1.1 Safety standards

accompanying eMC DocumentsThis medical electrical equipment needs special precautions regarding EMC and needs to be installed

and put into service according to the EMC information provided in this manual.

• Portable and mobile RF communications equipment can affect medical electrical equipment.

• Use of accessories, transducers and cables other than those specified, with the ex¬ception of acces-

sories, transducers and cables sold by the manufacturer of this equipment, as replacement parts for

internal and external components, may result in increased emissions or decreased immunity of the

equipment.

• The Balance System SD should not be used adjacent to or stacked with other equipment. If the

Balance System SD is used while positioned adjacent to other equipment, it should be observed to

verify normal operation in the configuration in which it will be used.

list of Cable accessoriesThe list in Table 1.2 includes all accessory cables supplied with the Balance System SD for which the

manufacturer of this equipment claims compliance to EN 60601-1-2 when used with the Balance

System SD.

Table 1.2 Balance System SD cables

APPENDIX E

— E-1 — APPENDIX E

Standard edition and/or date

IEC60601-1-2 First edition, 2007

Cable Description Part No. Cable length

USB Printer Cable Biodex # C12086 15ft

Declaration of Conformity

emissionsManufacturer’s declaration electromagnetic emissions

The Balance System SD is intended for use in the electromagnetic environment specified below. The

customer or the user of the Balance System SD should assure that it is used in such an environment.

emission test Compliance electromagnetic environment

RF emissions CISPR 11 Group 1 The Balance System SD generates RF energy

only for its internal functions. Therefore, its RF

emission is very low and is not likely to cause

any interference in nearby electronic equipment

RF emissions CISPR 11 Class A The Balance System SD is suitable for use in all

establishments other than domestic and those

directly connected to the public low-voltage

power supply network supplying buildings

used for domestic purposes.

Harmonic distortion Class A

EN 61000-3-2

Voltage fluctuations Complies

and flickerEN 61000-3-3

ImmunityManufacturer’s declaration electromagnetic immunity

The Balance System SD is intended for use in the electromagnetic environment specified below. The

customer or the user of the Balance System SD should assure that it is used in such an environment.

Immunity test IeC 60601-1-2 IeC 60601-1-2 electromagnetic test level Compliance level environment – guidance

Electrostatic discharge ± 6 kV contact Contact ± 6 kV Floor should be wood,

concrete or ceramic tiles.

If floor is covered with

synthetic material, the

relative humidity should

be at least 30%

Electrical fast ± 2 kV for power lines Power ± 2 kV Mains power quality

transients/burst ± 1 kV for Signal ± 1 kV should be that of a

IEC 61000-4-4 input/output lines typical commercial or

hospital environment

Surge ± 1 kV differential mode ± 1 kV diff. mode Mains power quality

IEC 61000-4-5 ± 2 kV common mode ± 2 kV com. mode should be that of a

typical commercial or

hospital environment

CONTENTS

APPENDIX E — E-2 —

Immunity test IeC 60601-1-2 IeC 60601-1-2 electromagnetictest level Compliance level environment – guidance

Voltage dips, short < 5% UT (> 95% of dip < 5% UT (> 95% of dip Mains power quality shouldinterruptions and in UT for 1/2 cycle) in UT) for 1/2 cycle be that of a typical commercialvoltage variations 40% UT (60% of dip 40% UT (60% of dip or hospital environment.on power supply in UT) for 5 cycle in UT) for 5 cycle If a better mains powerinput lines 70% UT (30% of dip 70% UT (30% of dip quality is required, it isIEC 61000-4-11 in UT) for 25 cycle in UT) for 25 cycle recommended that the

< 5% UT (> 95% of dip < 5% UT (> 95% of dip Balance System SD isin UT) for 5 sec in UT) for 5 sec powered from an uninter-

ruptible power supply

Power frequency 3 A/m 3 A/m If image distortion occurs,(50/60 Hz) magnetic it may be necessary tofield position the Balance System IEC 61000-4-8 SD display further from

sources of power frequencymagnetic fields or toinstall magnetic shielding.The power frequencymagnetic field should bemeasured in the intened installation location to assure that it is sufficiently low

Conducted RF 3 Vrms, 3 Vrms, Portable and mobile RFIEC 61000-4-6 150 KHz to 80 MHz 150KHz to 80 MHz communications equipment

should be used no closer to Radiated RF 3 V/m, 3 V/m, any part of the Balance Sysem IEC 61000-4-3 80 MHz to2.5 GHz 80 MHz to2.5 GHz SD, including cables,

than the recommended sep-aration distance calculated fromthe equation applicable to thefrequency of the transmitter.Recommended separation distance:d = 1.2√ P 150 KHz to 80 MHzd = 1.2√ P 80 MHz to 800 MHzd = 2.3√ P 800 MHz to 2.5 GHzwhere P is the maximum output power rating of the transmitter in watt (W) according to the transmitter manufacturer, and is the recommended separtion distance in meters (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b

Interference may occur in the vicinity of equip-ment marked withthe following symbol:

CONTENTS

— E-3 — APPENDIX E

Continued from previous page

NOTE 1: UT is the a.c. mains voltage prior to application of the test level. NOTE 2: At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 3: These guidelines may not apply in all situations.Electromagnetic propagation is affected by absorption and reflections fromstructures, objects and people

a Field strength from mixed transmitters, such as base stations for

radio telephones and land mobile radios, amateur radio, AM or FM

broadcast and TV broadcast cannot be predicted theoretically with

accuracy. To assess the electromagnetic environment due to fixed

RF transmitters, an electromagnetic site survey should be consid-

ered. If the measured field strength in the location in which the

Balance System SD is used exceeds the applicable RF compliance

levels above, the Balance System SD should be observed to verify

normal operation. If abnormal performance is observed, additional

measures may be necessary, such as re¬orienting or relocating the

Balance System SD.b Over the frequency range 150 KHz to 80 MHz, field strengths

should be less than 3 V/m.

Recommended Separation DistancesRecommended separation distances between portable and mobile RF communications equipment and

the Balance System SD. Table 6

The Balance System SD is intended for use in the electromagnetic environment in which radiated RF

disturbance are controlled. The customer or the user of the Balance System SD can help prevent elec-

tromagnetic interference by maintaining a minimum distance between portable and mobile RF com-

munication equipment (transmitters) and the Balance System SD as recommended below, according

to the maximum output power of the communication equipment.

Rated maximum output power of transmitter [W] Separation distance according to frequency of transmitter [m]

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

d = 1.2√ P d = 1.2√ P d = 2.3√ P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation

distance d in meters (m) can be estimated using the equation applicable to the frequency of the trans-

mitter, where P is the maximum output power rating of the transmitter in watts (W) according to the

transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorp-tion and reflection from structures, objects and people.

operating temperatureDo not expose the equipment to a temperature change of more than 5° F (3° C) per hour.

Limits of low and high operating temperature ranges are 59° to 86° F (15° C to 30° C).

CONTENTS

APPENDIX E — E-4 —

CleaNING aND MaINteNaNCe

General MaintenanceThe Biodex Balance SD requires only the most basic general maintenance, performed on an as-needed basis at least every three to four months.

Cleaning InstructionsWith the system turned OFF, wipe down all surfaces with a damp cloth. Mild soap and watercan be used to remove stains and scuff marks. As needed, inspect all locking and adjustmentmechanisms for signs of wear or damage.

If you have any questions or need further assistance, contact the Biodex Customer ServiceDepartment.

CAUTION: Some steps of these procedures require the Balance SD to be turned ON. When this isthe case, use extreme caution working on the system.

ATTENTION: Certaines étapes de la présente marche à suivre nécessitent que le système d’équili-brage soit mis SOUS TENSION. En pareille circonstance, user de précautions extrêmes dans lamaniplation du système.

APPENDIX F

— F-1 — APPENDIX F

ReFeReNCeS

Biblography available at www.biodex.com/balance

AKBARI, M, et al.BALANCE PROBLEMS AFTER UNILATERAL LATERAL ANKLE SPRAINSJ of Rehabilitation Research & Development (JRRD), Vol. 43, No. 7 : 819-824, Nov/Dec 2006Biodex #91-159

ALLET, L, et al.THE GAIT AND BALANCE OF PATIENTS WITH DIABETES CAN BE IMPROVED: A RANDOMISED CONTROLLED TRIALDiabetologia, 2010: Vol. 53:458-466Biodex #92-292

ARNOLD, BL, et al.NORMAL STABILITY PATTERNS AND RELATIONSHIP AS ASSESSED WITH THE BIODEXBALANCE SYSTEMJ of Athletic Training, Vol. 32 (2):S-25 / April-June 1997Biodex #93-268

EXAMINATION OF BALANCE MEASURES PRODUCED BY THE BIODEX STABILITY SYSTEMJ of Athletic Training, Vol. 33(4):323-27, Dec. 1998Biodex #93-287

AYDOG, E, et al.EVALUATION OF DYNAMIC POSTURAL BALANCE USING THE BIODEX STABILITY SYSTEMIN RHEUMATOID ARTHRITIS PATIENTSAbstract only - Clin Rheumatol, 2005, Oct 25:1-6Biodex #92-286

DYNAMIC POSTURAL BALANCE IN ANKYLOSING SPONDYLITIS PATIENTSAbstract only – Rheumatology (Oxford), 2005, Nov. 8Biodex #93-105

BALLARD, TPRODUCT PROFILE: THE BIODEX BALANCE SYSTEMBiodex Medical SystemsBiodex #91-111

BALDWIN, S, et alRELIABILITY OF DYNAMIC BILATERAL POSTURAL STABILITY ON THE BIODEX STABILITYSYSTEM IN OLDER ADULTSMed Sci Sports Exer, 2004; 36(5):S30Biodex #92-295*

BEHAN, EA COMPARISON OF A DYNAMIC BALANCE SYSTEM TO A STATIC FORCE PLAST SYS-TEM FOR ORTHOPEDIC AND MUSCULOSKELETAL REHABILITATIONBiodex Medical SystemsBiodex #91-113

APPENDIX G

— G-1 — APPENDIX G

A B J B

BLACKBURN, JT, et al.BALANCE AND JOINT STABILITY:THE RELATIVE CONTRIBUTIONS OF PROPRIOCEPTION AND MUSCULAR STRENGTHJ of Athletic Training, Vol. 34(2):S-30 / April-June 1999Biodex #91-104

BLACKBURN, TA, et al.SINGLE LEG STANCE: DEVELOPMENT OF RELIABLE TESTING PROCEDUREBerkshire Institute of Orthopedic & Sports Physical Therapy, Wyomissing, PA Biodex #93-207

REHABILITATION AFTER LIGAMENTOUS AND LABRAL SURGERY OF THE SHOULDER:GUIDING CONCEPTSJ of Athletic Training 2000; 35(3):373-381Biodex #93-111

CACHUPE, WJC, et al.RELIABILITY OF BIODEX BALANCE SYSTEM MEASURESHuman Performance Dept. / San Jose State University / June 2000Biodex #91-198

CAGGIANO, NA, et al.THE RELATIONSHIP BETWEEN ANKLE KINESTHESIA AND PEAK TORQUE WITHSINGLE LEG MULTIAXIAL PLATFORM STABILITYJ of Athletic Training, Vol. 34(2):S-31 / April-June 1999Biodex #91-106

CAKAR, E, et al.THE ANKLE-FOOT ORTHOSIS IMPROVES BALANCE AND REDUCES FALL RISK OFCHRONIC SPASTIC HEMIPARETIC PATIENTSEur J Phys Rehabil Med, 2010, Vol 46, No. 3, 363-368Biodex #92-290

JUMPING COMBINED EXERCISE PROGRAMS REDUCE FALL RISK AND IMPROVE BALANCE AND LIFE QUALITY OF ELDERLY PEOPLE WHO LIVE IN A LONG-TERM CAREFACILITYEur J Phys Rehabil Med, 2010, Vol 46, No. 1, 59-67Biodex #92-291

CAMPBELL, MH, et al.THE CORRELATION BETWEEN ISOKINETIC STRENGTH MEASURES AND FUNCTIONALPERFORMANCE IN AN ELDERLY POPULATIONBiodex #93-293

CAVANAUGH, JT, et al.BALANCE AND POSTOPERATIVE LOWER EXTREMITY JOINT RECONSTRUCTION

Orthopaedic Phys Therapy Clinics of No America; Vol.11:1, 75-99 - March 2002Biodex #92-244

CONTENTS

APPENDIX G — G-2 —

CHO, KH, et al.EFFECT OF LOWER LIMB STRENGTH ON FALLS AND BALANCE OF THE ELDERLYAnn Rehabil Med 2012; 36: 386-393Biodex #92-311

CLARK, S, et al.GENERALIZABILITY OF THE LIMITS OF STABILITY TEST IN THE EVALUATION OFDYNAMIC BALANCE AMONG OLDER ADULTSArch Phys Med Rehabil. Vol. 78:1078-1084, October 199792-269

DiCOSTANZA, K, et al.EFFECT OF ADHESIVE MEDIAL LONGITUDINAL ARCH SUPPORT ON POSTURAL SWAYJ of Athletic Training / Vol. 36(2) (supp) S66, April-June 2001Biodex #92-227

DOVER, G, et al.RELIABILITY OF INVERSION AND EVERSION PEAK TORQUE MEASUREMENTS FROMTHE BIODEX SYSTEM 3 ISOKINETIC DYNAMOMETERJ of Athletic Training / Vol. 35 (2) (supp) / S-91 / April-June 2000Biodex #91-185

FERRIS, CM, et al.A COMPARISON OF STRENGTH, PROPRIOCEPTION, LAXITY, FLEXIBILITY, AND BALANCEBETWEEN BASKETBALL AND NON-BASKETBALL COLLEGIATE FEMALE ATHLETESJ of Athletic Training / Vol. 35 No. 2 (supp) / S38 / April-June 2000Biodex #91-189

FINN, JA, et al.STABILITY PERFORMANCE ASSESSMENT AMONG SUBJECTS OF DISPARATE BALANCING ABILITIESSouthern Connecticut State University, 501 Crescent St., New Haven, CT 06515 Phone: 203-392-6036Biodex #93-286

FLYNN, WL, et al.CHANGES IN DYNAMIC POSTURAL STABILITY FOLLOWING CRYOTHERAPYJ of Athletic Training, Vol. 32(2):S-6 / April-June 1997Biodex #91-110

FREIDHOFF, G, et al.PILOT ASSESSMENT OF THE BIODEX STABILITY SYSTEM WITH NORMALS: TEST/RETEST AND DAY TO DAY RELIABILITYUniversity of Kentucky, Div. of P.T., (Med. Center Annex I, Lexington, KY)Biodex #93-206

CONTENTS


HANDRAKIS, JPSTATIC STRETCHING DOES NOT IMPAIR PERFORMANCE IN ACTIVE MIDDLE-AGEDADULTSJournal of Strength & Conditioning Research:March 2010 – Volume 24 – Issue 3 – pp 825-830Biodex #92-294

HINMAN, MRFACTOS AFFECTING RELIABILITY OF THE BIODEX BALANCE SYSTEM:A SUMMARY OF FOUR STUDIESJ of Sport Rehab, Vol. 9 (3):240-52, August 2000Biodex #91-194

HORNYIK, ML, et al.RELIABILITY OF LIMITS OF STABILITY TESTING: A COMPARISON OF TWO DYNAMICPOSTURAL STABILITY EVALUATION DEVICESJ of Athletic Training, Vol. 36(2) (supp) S78, April-June 2001Biodex #92-229

HORODYSKI, MB, et al.MEASUREMENTS OF DYNAMIC POSTURAL STABILITY, VISUAL SCANNING, AND MEN-TAL FLEXIBILITY IN COLLEGIATE FOOTBALL PLAYERSJ of Athletic Training, Vol. 34(2):S85 / April-June 1999Biodex #91-108

JORDEN, RA, et al.THE INFLUENCE OF ANKLE ORTHOSES AND EXERCISE ON POSTURAL STABILITYJ of Athletic Training, Vol. 36(2) (supp):S-78, April-June 2001Biodex #92-228

LAUFER, Y, et al.EFFECT OF ATTENTION FOCUS ON ACQUSITION AND RETENTION OF POSTURAL CON-TROL FOLLOWING ANKLE SPRAINArch Phys Med Rehabil, Vol 88, Jan 2007:105-108Biodex #92-285

LEONARD, K, et al.CHANGES IN DYNAMIC POSTURAL STABILITY FOLLOWING CRYOTHERAPY TO THEANKLE AND KNEEJ of Athletic Training, Vol. 34(2):S-68 / April-June 1999Biodex #91-107

LEPHART, S, et al.LEARNING EFFECTS AND RELIABILITY OF THE BIODEX STABILITY SYSTEMSports Medicine & Neuromuscular Laboratory, Univ. of Pittsburgh / Pittsburgh, PA Biodex #93-208

PROPRIOCEPTION FOLLOWING ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTIONJ of Sport Rehabilitation, Vol 1: 188-196 / 1992Biodex #92-283

CONTENTS


THE ROLE OF PROPRIOCEPTION IN THE MANAGEMENT AND REHABILITATION OFATHLETIC INJURIESThe Am J of Sports Med, Vol. 25, No. 1: 130-137 / 1997Biodex #92-284

LINDEMANN, U, et al.IMPROVING BALANCE BY IMPROVING MOTOR SKILLSZ Gerontol Geriat 37:20-26 (2004)Biodex #93-205

MAGILL, J, et al.CHANGES IN DYNAMIC POSTURAL STABILITY WITH THE USE OF NEOPRENE SLEEVESJ of Athletic Training, Vol. 34(2), S-30 / April-June 1999Biodex #91-103

MALLEY, C, et al.THE EFFECTS OF THREE DIFFERENT ANKLE TRAINING PROGRAMS ON FUNCTIONALSTABILITY AND SINGLE-LIMB STANCEJ of Athletic Training, Vol. 34(2), S-30 / April-June 1999Biodex #91-105

MATTACOLA, CG, et al.STRENGTH, FUNCTIONAL OUTCOME, AND POSTURAL STABILITY CRUCITATELIGAMENT RECONSTRUCTIONJ of Athletic Training, Vol. 37(3): 262-268 / July-Sept 2002Biodex #92-241

MELZER, I, et al.POSTURAL STABILITY IN THE ELDERLY: A COMPARISON BETWEEN FALLERS ANDNON-FALLERSAge and Ageing, 2004; 33(6): 602-7Biodex #92-288 (Abstract)

MYER, GD, et al.REHABILITATION AFTER ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: CRITE-RIA-BASED PROGRESSION THROUGH THE RETURN-T0-SPORT PHASEJ of Orthop & Sports Phy Ther, 36;6:385-402, June 2006Biodex #93-117

NELSON, AJ, et al.USING THE BIODEX UNWEIGHING SYSTEM, BALANCE SYSTEM AND GAIT TRAINER INAN INTEGRATED REHABILITATION PROGRAMAbstract, May 2001Biodex #92-217

PAJALA, S, et al.FORCE PLATFORM BALANCE MEASURES AS PRDICTORS OF INDOOR AND OUTDOORFALLS IN COMMUNITY-DWELLING WOMEN AGED 63-76 YEARSJ Gerontol A Biol Sci Med Sci, 2008; 63(2):171-8Biodex #92-289 (Abstract)

CONTENTS


PALM, H-G, et al.THE ROLE AND INTERACTION OF VISUAL AND AUDITORY AFFERENTS IN POSTURALSTABILITYGait & Posture, Oct 2009, Vol 30, Issue 3, 328-333Biodex #92-296

PARRACA, J, et al.TEST-RETEST RELIABILITY OF BIODEX BALANCE SD ON PHYSICALLY ACTIVE OLD PEOPLEJournal of Human Sport & Exercise, 2011, (issue 2, vol 8):444-451Biodex #92-287

PATERNO, MV, et al.THE RETURN OF NEUROMUSCULAR COORDINATION AFTER ANTERIOR CRUCIATELIGAMENT RECONSTRUCTIONBiodex Medical SystemsBiodex #91-112

PATERNO, MV, et al.NEUROMUSCULAR TRAINING IMPROVES SINGLE-LIMB STABILITY IN YOUNG FEMALEATHLETESJOSPT, Vol. 34 (6):305-316, June 2004Biodex #92-245

PEREIRA, HM, et al.INFLUENCE OF KNEE POSITION ON THE POSTURAL STABILITY INDEX REGISTERED BYTHE BIODEX STABILITY SYSTEMGait & Posture, Nov 2008, Vol 28, Issue 4, 668-672Biodex #92-293

PINTO, KK, et al.THE EFFECTS OF ANKLE TAPING AND BALANCE ACTIVITIES ON BIODEX STABILITYMEASUREMENTSJ of Athletic Training, Vol. 34(2), S-30 / April-June 1999Biodex #91-102

RIEMANN, BL, et al.COMPARISON OF THE ANKLE, KNEE, HIP, AND TRUNK CORRECTIVE ACTION SHOWNDURING SINGLE-LEG STANCE ON FIRM, FOAM, AND MULTIAXIAL SURFACESArch Phys Med Rehabil, Vol. 84: 90-95, January 200392-237

ROZZI, SL, et al.KNEE JOINT LAXITY AND NEUROMUSCULAR CHARACTERISTICS OF MALE ANDFEMALE SOCCER AND BASETBALL PLAYERSAmerican J Sports Med, Vol. 27(3):312-319 / May-June 1999Biodex #91-101

SCHMITZ, RJ, et al.INTERTESTER AND INTRATESTER RELIABILITY OF A DYNAMIC BALANCE PROTOCOLUSING THE BIODEX STABILITY SYSTEMJ of Sports Rehab 7:95-101, 1998Biodex #93-271

CONTENTS


SIERI, T and BERETTA, G.FALL RISK ASSESSMENT IN VERY OLD MALES AND FEMALES LIVING IN NURSINGHOMESDisability and Rehabilitation: 2004, Vol. 26, No. 12:718-723 Biodex #93-106

SIUDMAK, PG, et al.CORRELATIONS BETWEEN DYNAMIC BALANCE PERFORMANCE AND ISOKINETIC FUNCTIONS OF KNEE FLEXOR/EXTENSOR MUSCLES IN THE ELDERLYBiodex #93-295

TESTERMAN, C, et al.EVALUATION OF ANKLE INSTABILITY USING THE BIODEX STABILITY SYSTEMFoot Ankle Int 1999 May, 20(5):317-21 (ISSN: 1071-1007)Biodex #91-116

UUSI-RASI, K, et al.ASSOCIATIONS OF CALCIUM INTAKE AND PHYSICAL ACTIVITY WITH BONE DENSITYAND SIZE IN PREMENOPAUSAL AND POSTMENOPAUSAL WOMEN: A PERIPHERALQUANTITATIVE COMPUTED TOMOGRAPHY STUDYJ of Bone and Mineral Research, Vol 17, No. 3, 2002: 544-552Biodex #92-281

WILKERSON, GBDYNAMIC JOINT STABILITY: MECHANICAL AND NEUROMUSCULAR INTER-RELATIONSHIPSBiodex Medical SystemsBiodex #91-109

WINTERS, KM, et al.DETRAINING REVERSES POSITIVE EFFECTS OF EXERCISE ON THE MUSCULOSKELETALSYSTEM IN PREMENOPAUSAL WOMENJ of Bone and Mineral Research, Vol 15, No. 12, 2000: 2495-2503Biodex #92-280

(rev. Aug 2, 2012)

CONTENTS


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